Devices and methods for wearable injection guides

ABSTRACT

Wearable injection guides and manufacture and use thereof are described, which include: a rigid needle-penetrable material having an inner surface and an outer surface, the inner surface having form-fitting contours substantially conforming to a topography of a body region of an individual and the outer surface including one or more fiducials indication of at least one treatment parameter.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is related to and claims the benefit of theearliest available effective filing date(s) from the following listedapplication(s) (the “Related Applications”) (e.g., claims earliestavailable priority dates for other than provisional patent applicationsor claims benefits under 35 USC §119(e) for provisional patentapplications, for any and all parent, grandparent, great-grandparent,etc. applications of the Related Application(s)). All subject matter ofthe Related Applications and of any and all parent, grandparent,great-grandparent, etc. applications of the Related Applications,including any priority claims, is incorporated herein by reference tothe extent such subject matter is not inconsistent herewith.

RELATED APPLICATIONS

For purposes of the USPTO extra-statutory requirements, the presentapplication constitutes a continuation-in-part of U.S. patentapplication No. 13/567,921, entitled DEVICES AND METHODS FOR WEARABLEINJECTION GUIDES, naming Mahalaxmi Gita Bangera, Edward S. Boyden,Gregory J. Della Rocca, Daniel Hawkins, Roderick A. Hyde, Muriel Y.Ishikawa, Jordin T. Kare, Robert Lancer, Eric C. Leuthardt, Stephen L.Malaska, Para c Jitendra Parikh, Terence Myckatyn, Elizabeth A. Sweeney,Michael Smith, Clarence T. Tegreene, Sharon L. Wolda, and Lowell L.Wood, Jr. as inventors, filed 6 Aug. 2012, which is currently co-pendingor is an application of which a currently co-pending application isentitled to the benefit of the filing date.

For purposes of the USPTO extra-statutory requirements, the presentapplication constitutes a continuation-in-part of U.S. patentapplication No. 13/568,033, entitled SYSTEMS AND METHODS FOR WEARABLEINJECTION GUIDES, naming Mahalaxmi Gita Bangera, Edward S. Boyden,Gregory J. Della Rocca, Daniel Hawkins, Roderick A. Hyde, Muriel Y.Ishikawa, Jordin T. Kare, Robert Langer, Eric C. Leuthardt, Stephen L.Malaska, Para Jitendra Parikh, Terence Myckatyn, Elizabeth A. Sweeney,Michael Smith, Clarence T. Tegreene, Sharon L. Wolda, and Lowell L.Wood, Jr. as inventors, filed 6 Aug. 2012, which is currently co-pendingor is an application of which a currently co-pending application isentitled to the benefit of the filing date.

The United States Patent Office (USPTO) has published a notice to theeffect that the USPTO's computer programs require that patent applicantsreference both a serial number and indicate whether an application is acontinuation, continuation-in-part, or divisional of a parentapplication. Stephen G. Kunin, Benefit of Prior-Filed Application, USPTOOfficial Gazette Mar. 18, 2003. The present Applicant Entity(hereinafter “Applicant”) has provided above a specific reference to theapplication(s) from which priority is being claimed as recited bystatute. Applicant understands that the statute is unambiguous in itsspecific reference language and does not require either a serial numberor any characterization, such as “continuation” or“continuation-in-part,” for claiming priority to U.S. patentapplications. Notwithstanding the foregoing, Applicant understands thatthe USPTO's computer programs have certain data entry requirements, andhence Applicant has provided designation(s) of a relationship betweenthe present application and its parent application(s) as set forthabove, but expressly points out that such designation(s) are not to beconstrued in any way as any type of commentary and/or admission as towhether or not the present application contains any new matter inaddition to the matter of its parent application(s).

SUMMARY

In an aspect, a wearable injection guide includes, but is not limitedto: a rigid material formed to substantially conform in shape to atopography of a body region of an individual, the rigid materialsubstantially impenetrable to an injection needle, and the rigidmaterial including one or more injection needle access regions arrangedin a treatment pattern. In addition to the foregoing, other deviceaspects are described in the claims, drawings, and text forming a partof the present disclosure.

In an aspect, a method of administering an injection treatment to a skinregion includes, but is not limited to: inserting one or more injectionneedles through one or injection needle access regions of a wearableinjection guide, the wearable injection guide constructed of a rigidmaterial formed to substantially conform in shape to a topography of abody region of an individual, the one or more injection needle accessregions arranged in a treatment pattern; and injecting at least oneinjectable agent through the one or more injection needles into anunderlying tissue of the body region of the individual. In addition tothe foregoing, other method aspects are described in the claims,drawings, and text forming a part of the present disclosure.

In an aspect, a wearable injection guide includes, but is not limitedto: a rigid material substantially impenetrable to an injection needle,the rigid material including one or more injection needle access regionsarranged in a treatment pattern, the one or more injection needle accessregions including one or more activatable injection event indicators. Inaddition to the foregoing, other device aspects are described in theclaims, drawings, and text forming a part of the present disclosure.

In an aspect, a wearable injection guide includes, but is not limitedto: a rigid needle-penetrable material having an inner surface and anouter surface, the inner surface having form-fitting contourssubstantially conforming to a topography of a body region of anindividual and the outer surface including one or more fiducialsindicative of at least one treatment parameter. In addition to theforegoing, other device aspects are described in the claims, drawings,and text forming a part of the present disclosure.

In an aspect, a method of administering an injection treatment to anindividual includes, but is not limited to: aligning one or morealignment marks of a wearable injection guide with one or more referencepoints on a body region of an individual, the wearable injection guideincluding a rigid needle-penetrable material with an inner surface andan outer surface, the inner surface having a form fitting contoursubstantially conforming to the topography of the body region of theindividual and the outer surface having one or more fiducials indicativeof at least one treatment parameter; immobilizing the wearable injectionguide on the body region of the individual; inserting one or moreinjection needles through the rigid needle-penetrable material of thewearable injection guide at or near the one or more fiducials; andinjecting at least one injectable agent through the one or moreinjection needles into an underlying tissue of the body region of theindividual. In addition to the foregoing, other method aspects aredescribed in the claims, drawings, and text forming a part of thepresent disclosure.

In an aspect, a wearable injection guide includes, but is not limitedto: a needle-penetrable material having an inner surface, an outersurface, and one or more activatable injection event indicators, theinner surface having form-fitting contours substantially conforming to atopography of a body region of an individual and the outer surfaceincluding one or more fiducials indicative of at least one treatmentparameter. In addition to the foregoing, other device aspects aredescribed in the claims, drawings, and text forming a part of thepresent disclosure.

In an aspect, a method of generating a wearable injection guide for anindividual includes, but is not limited to: acquiring one or moredigital images of a body region of the individual; creating a digitallyrendered model of the wearable injection guide from the one or moredigital images of the body region of the individual; adding one or moredigitally rendered fiducials indicative of at least one treatmentparameter to the digitally rendered model of the wearable injectionguide; and forming the wearable injection guide from the digitallyrendered model of the wearable injection guide, the formed wearableinjection guide including one or more fiducials indicative of the atleast one treatment parameter, the one or more fiducials correspondingto the one or more digitally rendered fiducials on the digitallyrendered model of the wearable injection guide. In addition to theforegoing, other method aspects are described in the claims, drawings,and text forming a part of the present disclosure.

In an aspect, a method of generating a wearable injection guide for anindividual includes, but is not limited to: acquiring one or moredigital images of a body region of the individual; creating a digitallyrendered model of the wearable injection guide from the one or moredigital images of the body region of the individuals; adding one or moredigitally rendered injection needle access regions in a treatmentpattern to the digitally rendered model of the wearable injection guide;and forming the wearable injection guide from the digitally renderedmodel of the wearable injection guide, the formed wearable injectionguide including one or more injection needle access regions, the one ormore injection needle access regions corresponding to the one or moredigitally rendered injection needle access regions on the digitallyrendered model of the wearable injection guide. In addition to theforegoing, other method aspects are described in the claims, drawings,and text forming a part of the present disclosure.

In an aspect, a method of generating a wearable injection guide for anindividual includes, but is not limited to: acquiring one or moredigital images of a body region of the individual; creating a digitallyrendered three-dimensional surface model of the body region; developinga treatment regimen specific to the individual based on analysis of thedigitally rendered three-dimensional surface model of the body region ofthe individual; adding one or more digitally rendered fiducialsindicative of at least one treatment parameter to the digitally renderedthree-dimensional surface model of the body region, the at least onetreatment parameter a component of the treatment regimen specific to theindividual; and printing the one or more digitally rendered fiducialsindicative of the at one treatment parameter onto a surface of apreformed wearable injection guide, the preformed wearable injectionguide configured to cover at least a portion of the body region of theindividual. In addition to the foregoing, other method aspects aredescribed in the claims, drawings, and text forming a part of thepresent disclosure.

In an aspect, a system for generating a wearable injection guide for anindividual includes, but is not limited to: at least one image capturedevice configured to acquire one or more digital images of a body regionof an individual and to transmit one or more output signals havinginformation associated with the one or more digital images; a computingdevice operably linked to the at least one image capture deviceincluding non-transitory machine readable media bearing one or moreinstructions for generating the wearable injection guide from the one ormore digital images of the body region of the individual, the one ormore instructions including one or more instructions for controlling oneor more functions of the at least one image capture device; one or moreinstructions for receiving the one or more output signals havinginformation associated with the one or more digital images from the atleast one image capture device; one or more instructions for creating adigitally rendered model of the wearable injection guide from the one ormore digital images of the body region of the individual; one or moreinstructions for adding one or more fiducials indicative of at least onetreatment parameter to the digitally rendered model of the wearableinjection guide; and one or more instructions for generating one or moremodel output signals having information for forming the wearableinjection guide from the digitally rendered model of the wearableinjection guide; and a manufacturing device configured to receive theone or more model output signals from the computing device and to formthe wearable injection guide from the digitally rendered model of thewearable injection guide, the formed wearable injection guide includingone or more fiducials indicative of the at least one treatmentparameter, the one or more fiducials corresponding to the one or moredigitally rendered fiducials on the digitally rendered model of thewearable injection guide. In addition to the foregoing, other systemaspects are described in the claims, drawings, and text forming a partof the present disclosure.

In an aspect, an article of manufacture includes, but is not limited to:non-transitory machine readable media bearing one or more instructionsfor generating a wearable injection guide for administering aninjectable agent to an individual, the one or more instructionsincluding: one or more instructions for controlling acquisition of oneor more digital images of a body region of the individual with at leastone image capture device; one or more instructions for receiving one ormore output signals having information associated with the one or moredigital images from the at least one image capture device; one or moreinstructions for creating a digitally rendered model of the wearableinjection guide from the one or more digital images of the body regionof the individual; one or more instructions for generating a treatmentregimen for the individual based on the one or more digital images ofthe body region; one or more instructions for adding one or moredigitally rendered fiducials indicative of at least one treatmentparameter of the treatment regimen to the digitally rendered model ofthe wearable injection guide; and one or more instructions forgenerating one or more model output signals having information formanufacturing the wearable injection guide from the digitally renderedmodel of the wearable injection guide. In addition to the foregoing,other article of manufacture aspects are described in the claims,drawings, and text forming a part of the present disclosure.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, embodiments,and features described above, further aspects, embodiments, and featureswill become apparent by reference to the drawings and the followingdetailed description.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A is a schematic of a wearable injection guide on a face of anindividual.

FIG. 1B is a schematic of an injection needle.

FIG. 2 is a schematic of a wearable injection guide on an abdominalregion of an individual.

FIG. 3A is a schematic of a cross-section through a wearable injectionguide on a body region.

FIG. 3B is a schematic of a cross-section through a wearable injectionguide and tissue layers.

FIG. 4 is a schematic of a wearable injection guide on a face of anindividual.

FIG. 5A is a schematic of a cross-section through a wearable injectionguide with one or more injection needles.

FIG. 5B is a schematic of a cross-section through a wearable injectionguide with one or more injection needles.

FIG. 5C is a schematic of a cross-section through a wearable injectionguide with one or more injection needles.

FIG. 6A is a schematic of a cross-section through a wearable injectionguide with an agent.

FIG. 6B is a schematic of a cross-section through a wearable injectionguide with an agent.

FIG. 6C is a schematic of a cross-section through a wearable injectionguide with an injection needle with an agent.

FIG. 6D is a schematic of a cross-section through a wearable injectionguide with an injection needle with an agent.

FIG. 7 is a schematic of a wearable injection guide on a face of anindividual.

FIG. 8 is a schematic of a wearable injection guide with activatableinjection event indicators.

FIG. 9A is a schematic of a cross-section through a wearable injectionguide prior to insertion of an injection needle.

FIG. 9B is a schematic of a cross-section through a wearable injectionguide during insertion of an injection needle.

FIG. 9C is a schematic of a cross-section through a wearable injectionguide after insertion of an injection needle.

FIG. 10A is a schematic of a cross-section through a wearable injectionguide prior to insertion of an injection needle.

FIG. 10B is a schematic of a cross-section through a wearable injectionguide during insertion of an injection needle.

FIG. 10C is a schematic of a cross-section through a wearable injectionguide after insertion of an injection needle.

FIG. 11A is a schematic of a cross-section through a wearable injectionguide prior to insertion of an injection needle.

FIG. 11B is a schematic of a cross-section through a wearable injectionguide during insertion of an injection needle.

FIG. 11C is a schematic of a cross-section through a wearable injectionguide after insertion of an injection needle.

FIG. 12A is a schematic of a cross-section through a wearable injectionguide prior to insertion of an injection needle.

FIG. 12B is a schematic of a cross-section through a wearable injectionguide during insertion of an injection needle.

FIG. 12C is a schematic of a cross-section through a wearable injectionguide after insertion of an injection needle.

FIG. 13 is a flowchart of a method of administering an injectiontreatment.

FIG. 14 is a flowchart illustrating aspects of a method such as shown inFIG. 13.

FIG. 15 is a flowchart showing aspects of a method such as depicted inFIG. 13.

FIG. 16 is a flowchart depicting aspects of a method such as illustratedin FIG. 13.

FIG. 17 is a flowchart illustrating aspects of a method such as shown inFIG. 13.

FIG. 18 is a flowchart showing aspects of a method such as depicted inFIG. 13.

FIG. 19 is a flowchart depicting aspects of a method such as illustratedin FIG. 13.

FIG. 20 is a flowchart of a method of administering an injectiontreatment.

FIG. 21 is a flowchart illustrating aspects of a method such as shown inFIG. 20.

FIG. 22 is a flowchart showing aspects of a method such as depicted inFIG. 20.

FIG. 23 is a flowchart depicting aspects of a method such as illustratedin FIG. 20.

FIG. 24 is a flowchart illustrating aspects of a method such as shown inFIG. 20.

FIG. 25 is a flowchart showing aspects of a method such as depicted inFIG. 20.

FIG. 26 is a flowchart depicting aspects of a method such as illustratedin FIG. 20.

FIG. 27 is a flowchart of a method of generating a wearable injectionguide.

FIG. 28 is a flowchart illustrating aspects of a method such as shown inFIG. 27.

FIG. 29 is a flowchart showing aspects of a method such as depicted inFIG. 27.

FIG. 30 is a flowchart depicting aspects of a method such as illustratedin FIG. 27.

FIG. 31 is a flowchart illustrating aspects of a method such as shown inFIG. 27.

FIG. 32 is a flowchart showing aspects of a method such as depicted inFIG. 27.

FIG. 33 is a flowchart depicting aspects of a method such as illustratedin FIG. 27.

FIG. 34 is a flowchart illustrating aspects of a method such as shown inFIG. 27.

FIG. 35 is a flowchart showing aspects of a method such as depicted inFIG. 27.

FIG. 36 is a flowchart depicting aspects of a method such as illustratedin FIG. 27.

FIG. 37 is a flowchart illustrating aspects of a method such as shown inFIG. 27.

FIG. 38 is a flowchart illustrating aspects of a method such as shown inFIG. 27.

FIG. 39 is a flowchart of a method of generating a wearable injectionguide.

FIG. 40 is a flowchart of a method of generating a wearable injectionguide.

FIG. 41 is a schematic of a system for generating a wearable injectionguide

FIG. 42 is a schematic showing aspects of a system such as that depictedin FIG. 41.

FIG. 43 is a schematic of an article of manufacture.

FIG. 44 is a schematic of a wearable injection guide.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description and drawings are not meant to be limiting. Otherembodiments may be utilized, and other changes may be made, withoutdeparting from the spirit or scope of the subject matter presented here.

A wearable injection guide is described for guiding injection of one ormore injection needles containing at least one injectable agent into abody region of an individual for treatment of one or more conditions. Awearable injection guide can be configured for deployment on any of anumber of body regions of an individual including but not limited to theface, torso, abdomen, head, neck, upper extremity, lower, extremity,buttocks, or any other body region assessable for needle injection. Awearable injection guide can be used for guiding injection of injectableagents used to treat any of a number of conditions including but notlimited to a cosmetic condition (e.g., wrinkles, sagging skin), pain(e.g., migraine), neurological disorders (e.g., idiopathic neuropathy),neuromuscular disorder (e.g., cervical dystonia, blepharospasm),inflammation (e.g., arthritis, psoriasis), vascular disorder (e.g.,varicose veins, rosacea, Reynaud's Syndrome), cancer, infection (e.g.,bacterial or viral infection), endocrine condition, metabolic condition(e.g., diabetes), infertility (e.g., ovulatory stimulation for in vitrofertilization), or vitamin deficiency (e.g., vitamin B deficiency). Theat least one injectable agent can include any of a number of injectableagents including but not limited to neurotoxins, subcutaneous volumeenhancers, dermal fillers, insulin, antibiotics, hormones,chemotherapeutic, or biological agents.

With reference to FIG. 1, shown is a schematic view of a wearableinjection guide 100 on a face of an individual. Wearable injection guide100 includes rigid material 110 formed to substantially conform in shapeto a topography of a body region of an individual, e.g., the face 120.In this non-limiting example, wearable injection guide 100 covers almostthe entirety of the individual's face. In some embodiments, the rigidmaterial 110 of the wearable injection guide 100 may be designed tocover less than the entirety of a body region. For example, a wearableinjection guide for use in guiding injection of injectable agents intoan individual's face may cover one or more of the forehead, eyes, cheeksor mouth, depending upon the treatment regimen. For example, a wearableinjection guide for use in cosmetically treating frown lines of theforehead or crow's feet near the eyes may include rigid materialcovering only the forehead and eyes of an individual's face.

The rigid material 110 of the wearable injection guide 100 may be formedfrom one or more materials substantially impenetrable to an injectionneedle. The one or more material substantially impenetrable to aninjection needle can include one or more material capable of beingshaped, molded or printed to form the wearable injection guide 100.Non-limiting examples of shapeable, moldable or printable materialsinclude acrylic, nylon, plastic, ceramic, resin, rubber, epoxy,thermoplastic, photopolymer, polyurethane, silicone, or latex. In someembodiments, all or part of the rigid material is transparent, to allowa physician, other practitioner, or the individual to see through thewearable injection guide to the underlying surface of the body region.The shapeable, moldable or printable materials may be further hardenedinto a material substantially impenetrable to an injection needle usingone or more stimuli. In some embodiments, the shapeable, moldable orprintable materials may simply harden over an elapsed time period or byexposure to ambient air. In some embodiments, the shapeable, moldable orprintable material may be hardened in response to electromagneticenergy, e.g., light of a specific wavelength, or in response to elevatedtemperature.

The wearable injection guide 100 may be formed from shapeable, moldable,or printable materials by a variety of manufacturing methods. In someembodiments, the wearable injection guide 100 is generated from a moldmade of the body region of the individual. For example, a mold of a bodyregion of an individual can be generated by covering the body region,e.g., an individual's face, with a material that hardens to conform inshape to a topography of the body region. For example, alginate may beused in combination with plaster bandages to create a mold of a bodyregion of an individual, e.g., the individual's face. In someembodiments, the mold itself can be used as a preformed wearableinjection guide. Non-limiting examples of materials that can be used forgenerating a mold of a body region of an individual include modelingclay, plaster, alginate, or combinations thereof. In some embodiments,the mold can be a reusable template for forming one or more wearableinjection guides with a material, e.g., latex, that is poured or spreadinto the mold, hardened, and removed from the mold.

In some embodiments, the wearable injection guide 100 is formed usingdigitized information, e.g., digital images, regarding the topography ofthe body region of an individual in combination with a manufacturingmethod. The topography of the body region can include both themicro-topography of the skin surface, e.g., skin texture and patterning,as well as the topography of body features, e.g., cheeks, nose, lips,eye sockets, joints, and the like. In some embodiments, a computingdevice is used to generate a digitally rendered model of the wearableinjection guide based on the one or more digital images of the bodyregion of the individual. Information regarding the digitally-renderedmodel of the wearable injection guide is sent to a manufacturing devicewhich produces the wearable injection guide based on the receivedinformation. Non-limiting examples of methods for generating athree-dimensional structure from digitized information includestereolithography, laser sintering, fused deposition modeling, polyjet,three-dimensional printing, vacuum casting, reaction injection molding,or injection molding.

Returning to FIG. 1, the wearable injection guide 100 includes one ormore injection needle access regions 130 arranged in a treatment pattern140. The one or more injection needle access regions 130 are configuredto allow an injection needle to pass through the rigid material 110 ofthe wearable injection guide 100 to the underlying tissue of the bodyregion of the individual's face 120. In some embodiments, the one ormore injection needle access regions are configured to allow injectionneedles to only pass through wearable injection guide 100 in aprescribed treatment pattern at the injection needle access regions 130.In some embodiments, the one or more injection needle access regions 130are configured to allow an injection needle to readily pass through anotherwise needle-impenetrable rigid material 110. In some embodiments,at least one of the one or more injection needle access regions includesa diameter greater than an injection needle diameter. In someembodiments, the one or more injection needle access regions 130 includeone or more portions of the rigid material 110 having a reducedthickness sufficient to permit an injection needle penetration. In someembodiments, the one or more injection needle access regions 130 includeone or more portions of the rigid material 110 having a reduced hardnesssufficient to permit an injection needle penetration. The material inthe one or more injection needle access regions 130 can be the samematerial as rigid material 110, but it may be treated, processed, orcured differently to generate the access regions. In some embodiments,the material in the one or more injection needle access regions 130 canbe the same material used in rigid material 110 but is thinner or softerin the access regions. In an embodiment, the material in the one or moreinjection needle access regions 130 can be different from rigid material110 of wearable injection guide 100. In some embodiments, at least aportion of the rigid material is transparent proximal to or coincidentwith at least one of the one or more injection needle access regions.

In some embodiments, rigid material 110 can define one or more injectionneedle access regions 130 that are one or more openings in rigidmaterial 110. The one or more injection needle access regions 130including one or more openings defined by the rigid material can have across-section of any desired diameter. In some embodiments, the one ormore openings defined by the rigid material have a diameter greater thanan injection needle diameter. For example, the one or more injectionneedle access regions 130 including one or more openings defined by therigid material can be sized to allow injection needles of a specifieddiameter, e.g., gauge, to pass through the wearable injection guide 100and into the underlying tissue of the body region. The gauge of aninjection needle is inversely proportional to its outer diameter. Forexample, the injection needle access regions 130 can range in across-sectional diameter from about 5 millimeters (mm) to about 0.2 mm,to accommodate standard needle gauges that range from 7 gauge (outerdiameter approximately 4.6 mm) to 34 gauge (outer diameter approximately0.19 mm). In an embodiment, the one or more injection needle accessregions range in diameter from about 0.8 mm to about 0.3 mm toaccommodate needles ranging in size from 21 gauge to 32 gauge, which areinjection needle gauges commonly used to inject agents into the skin.Larger needles, i.e., needles with a larger diameter but a smaller gaugenumber, are associated with increased pain. Smaller needles, i.e.,needles with smaller diameter but larger gauge number, are less painfulbut are less able to accommodate viscous injectable agents.

In some embodiments, the one or more injection needle access regions 130of the wearable injection guide 100 are round in shape. However, theshape of the one or more injection needle access regions 130 is notrestricted to being circular in shape and can include, for example,oval, square, rectangular, trapezoid or triangular shapes (fornon-circular shapes, the term “diameter” as used herein refers to thelargest diameter of a cylindrical injection needle that is able to passthrough the opening). In general, the shape of the one or more injectionneedle access regions 130 is shaped to allow passage of an appropriatelysized injection needle through the rigid material 110 of the wearableinjection guide 100 and into the underlying tissue of the body region.The diameter of the one or more injection needle access regions 130 canbe designed to permit the passage of the needle therethrough with verylittle gap between the injection needle and the rigid material 110. Thisis useful for injections that require precise placement of the injectionneedle into the underlying tissue. In an embodiment, the diameter of theone or more injection needle access regions 130 openings can be designedto permit the passage of the injection needle therethrough with arelatively large gap between the injection needle and the rigid material110. This is useful for injections that can accommodate injection needleplacement in a more general or gross area of the underlying tissue,where accurate placement of the injection needle is not as important.

In some embodiments, the one or more injection needle access regions arelinear in shape, e.g., a line. One or more injection needle accessregions that are linear in shape can accommodate serial needle sticks orlinear threading along the path of the linear shape. As illustrated inFIG. 1, in some embodiments, the one or more injection needle accessregions can be one or more straight slits 132 in the wearable injectionguide. In some embodiments, the one or more injection needle accessregions can be one or more curved slits 134 in the wearable injectionguide. The one or more straight slits 132 and/or curved slits 134 can becontinuous or discontinuous depending upon the preferred treatmentpattern. In some embodiments, the one or more straight slits 132 and/orcurved slits 134 represent portions of rigid material 110 having reducedthickness or hardness sufficient to permit an injection needlepenetration. In some embodiments, the one or more straight slits 132and/or curved slits 134 represent portions of rigid material 110defining one or more openings.

In some embodiments, the wearable injection guide 100 includes one ormore injection needle access regions 130 comprising one or more areas ofthe rigid material 110 having a reduced thickness sufficient to permitan injection needle penetration. The reduction in thickness of the rigidmaterial in the injection needle access region can be about 0.1% toabout 100%. For example, a wearable injection guide can be formed inwhich the thickness of the rigid material within the injection needleaccess region is about 1-10% of the overall thickness of the rigidmaterial. The reduction in thickness of the rigid material within theinjection needle access regions can be added to a digitally renderedmodel of the wearable injection guide and incorporated into the formedwearable injection guide during manufacture.

In some embodiments, the wearable injection guide 100 includes one ormore injection needle access regions 130 comprising one or more areas ofrigid material 110 having reduced hardness to permit an injection needlepenetration. The reduction in hardness of the rigid material in theinjection needle access region can be about 0.1% to about 100%. Forexample, a wearable injection guide can be formed in which the hardnessof the rigid material within the injection needle access region is about1-10% of the overall hardness of the rigid material. In some instances,the injection needle access regions can include a different materialthan that used for the overall wearable injection guide. For example,the wearable injection guide 100 can be formed from acrylic and theinjection needle access regions formed from a soft rubber or latex. Insome instances, the injection needle access regions can include the samematerial that is used for the bulk of the rigid material of the wearableinjection guide, but treated, e.g., cured, differently from the rest ofthe rigid material.

The wearable injection guide 100 includes one or more injection needleaccess regions 130 arranged in a treatment pattern 140. In someembodiments, the one or more injection needle access regions 130 arearranged in a treatment pattern 140 that is predetermined. For example,the treatment pattern may be predetermined depending upon the type ofinjectable agent and/or the condition being treated. For example,cosmetic treatment of a portion of the face, e.g., the glabella frownlines, may follow a predetermined pattern of injection sites. In someembodiments, the predetermined treatment pattern is provided by acomputing device that stores treatment patterns specific for a conditionor specific for an injectable agent. In some embodiments, the one ormore injection needle access regions arranged in a treatment pattern canbe included in a digitally rendered model of the wearable injectionguide. For example, the one or more injection needle access regions 130may be arranged in a treatment pattern 140 based on the specific needsof the individual for whom the wearable injection guide is designed andmanufactured. In this case, the number and placement of the one or moreinjection needle access regions are specifically prescribed for theindividual.

In some embodiments, the one or more injection needle access regions 130can be arranged in a treatment pattern 140 that is generic for a giventreatment regimen. For example, the treatment pattern 140 can be aseries of rows and/or columns of injection needle access regions, anyone or more of which may be accessed during the course of treatment.

In some embodiments, the treatment pattern 140 is anatomical featuredependent. For example, a wearable injection guide designed fordeployment on the face of an individual may have a treatment patterndependent upon a particular anatomical feature of the face, e.g., theeye brow, the glabella, or cheek folds. In some embodiments, theanatomical feature can include an anatomical feature that might becontraindicated as an injection site, e.g., an underlying blood vessel,joint, or inside the orbit of the eye, and as such the one or moreinjection needle access regions are arranged in a treatment pattern toavoid this anatomical feature. In some embodiments, the anatomicalfeatures of the body region are fairly uniform, e.g., the anatomicalfeatures of the upper thigh, and as such the arrangement of the one ormore injection needle access regions into a treatment pattern can bemore generic or less specific to the individual.

In some embodiments, the arrangement of one or more injection needleaccess regions 130 into a treatment pattern 140 is dependent upon thespecific needs of the individual. In the case of a wearable injectionguide deployed on an individual's face for cosmetic use, for example,the arrangement of the one or more injection needle access regions intoa treatment pattern can include situating the one or more injectionneedle access regions over, for example, one or more lines, wrinkles,folds, or pouches in need of treatment on the individual's face. Theskin is composed of three layers: the outer epidermis, the dermis, andthe subcutis (hypodermis) or lowest layer of the skin. The dermis can befurther divided into the upper papillary region and the lower reticularregion. During youth, elastin and collagen contained in the dermisallows the epidermis to stretch and hold large amounts of moisture. Overtime, elastin and collagen are lost from the dermis and the skin becomesthinner and less elastic and stretchy. In addition, the dermis begins tohave difficulty moving adequate amounts of moisture up to the epidermis,causing the epidermis to sag and wrinkles to form. During aging,mechanical lines also begin to appear and are commonly associated withsquinting, e.g., crow's feet, smiling, e.g., laugh lines, or frowning,e.g., forehead frown lines. In some embodiments, the treatment patternon the wearable injection guide can include one or more injection needleaccess regions situated over one or more horizontal forehead lines,glabellar frown lines, periorbital lines, preauricular lines, cheeklines, nasolabial folds, upper radial lip lines, lower radial lip lines,corner of the mouth lines, marionette lines, labiomental crease, and/orhorizontal neck folds.

In some embodiments, a wearable injection guide 100 deployed on anindividual's face 120 can include one or more injection needle accessregions 130 arranged in a treatment pattern 140 that are situated overone or more muscles associated with creating lines and wrinkles on theindividual's face 120. For example, the treatment pattern on thewearable injection guide can include one or more injection needle accessregions situated over one or more of the occipito-frontalis muscle ofthe forehead for treatment of horizontal forehead wrinkles; the procerusmuscle between the eyebrows for treatment of horizontal wrinkling abovethe bridge of the nose; the corrugators muscle for treatment of the “11”wrinkles that appear between the eyebrows or in the glabella during anangry facial expression; the orbicularis oculi muscles around the eyesfor the treatment of “crow's feet;” the nasalis muscles of the nose forthe treatment of “bunny lines” along the side of the nose; theorbicularis oris muscles around the lips for the treatment of radialpucker lines on the lips; and the depressor anguli oris muscles underthe lips for the treatment of down turning of the corners of the mouthwhile frowning.

In some embodiments, the treatment pattern 140 can include one or moreinjection needle access regions 130 arranged in such a way as to createvolume upon injection of a filler substance. For example, a series ofinjection needle access regions can be arranged on a wearable injectionguide in a linear treatment pattern along a skin fold. In anotherexample, the injection needle access regions can be arranged on awearable injection guide in a square treatment pattern to facilitatethreading of an injectable agent in a crisscross pattern.

Returning to the example in FIG. 1, the one or more injection needleaccess regions 130 of the wearable injection guide 100 arranged in atreatment pattern 140 can further include one or more fiducials, e.g.,150 a, 150 b, and 150 c, indicative of at least one treatment parameter.In some embodiments, the one or more fiducials indicative of at leastone treatment parameter mark the site at which an injection needle isintended to be inserted through the wearable injection guide. In someembodiments, the one or more fiducials indicative of at least onetreatment parameter provide instructions as to what action should betaken at or near any of the one or more fiducials, e.g., what injectableagent to inject, the dose of the injectable agent, and/or how deep toinsert a needle into the underlying tissue of the body region.

In some embodiments, at least one of the one or more fiducialsindicative of the at least one treatment parameter is positionedproximal to at least one of the one or more injection needle accessregions. For example, an injection needle access region that is anopening in the rigid material of the wearable injection guide mayinclude one or more fiducials in proximity to the opening that indicateat least one treatment parameter relevant to that opening. In someembodiments, at least one of the one or more fiducials indicative of theat least one treatment parameter coincides with at least one of the oneor more injection needle access regions. For example, the one or morefiducials may coincide with a portion of the rigid material that hasreduced thickness or hardness corresponding to an injection needleaccess region.

In some embodiments, each of the one or more injection needle accessregions include one or more fiducials indicative of at least onetreatment parameter. In some embodiments, only a subset of the one ormore injection needle access regions include one or more fiducialsindicative of at least one treatment parameter. In some embodiments, theone or more fiducials indicative of at least one treatment parameter aregeneric and appropriate for use for anyone undergoing treatment for aspecific condition. In some embodiments, the one or more fiducialsindicative of at least one treatment parameter are specific to theindividual for whom the wearable injection guide is designed andmanufactured. For example, the type of injectable agent and/or dosagemay be based on the specific condition of the individual as well asother criteria, e.g., weight, age, skin thickness, allergic response, orother physiological criteria relevant to administration of an injectableagent.

In some embodiments, the at least one treatment parameter is part of atreatment regimen indicated for treatment of a specific condition. Thetreatment regimen can include one or more injectable agents, dosing ofthe one or more injectable agents, timing of dosing of each of the oneor more injectable agents, sequence of dosing of each of the one or moreinjectable agents, placement of dosing of each of the one or moreinjectable agents. For example, the treatment regimen may be representedby one or more fiducials indicating the time intervals at which aninjectable agent should be repeatedly injected through the wearableinjection guide at the same or different injection needle access regionover a period of time, e.g., over the course of a 30 to 60 minute officevisit. When two or more injectable agents are indicated for use in thecondition, the treatment regimen may be represented by one or morefiducials indicative of the sequence of injection of the two or moreinjectable agents.

The one or more fiducials can include one or more colors, numbers,letters, shapes, crosshairs, or combinations thereof indicative of atleast one treatment parameter. In the non-limiting example of FIG. 1,the one or more fiducials 150 a, 150 b, and 150 c are depicted as beingred (R), blue (B) and green (G), respectively, but it is understood thatthe one or more fiducials can include any combination of colors,numbers, letters, shapes, and/or crosshairs indicative of at least onetreatment parameter.

In an embodiment, the one or more fiducials 150 a, 150 b, and 150 cindicative of at least one treatment parameter include one or morefiducials 150 a, 150 b, and 150 c indicative of at least one type ofinjectable agent to be injected at at least one of the one or moreinjection needle access regions. For example, a cosmetic treatment ofthe face can include one or more fiducials indicative of at least oneinjectable agent, e.g., a neurotoxin, subcutaneous volume enhancer, ordermal filler (see, e.g., Carruthers et al., Plast. Reconstr. Surg.(2008) 121 (Suppl):5S-30S, which is incorporated herein by reference).Non-limiting examples of other injectable agents include insulin,antibiotics, hormones, chemotherapeutics or biological agents. In anembodiment, the one or more fiducials 150 a, 150 b, and 150 c indicativeof at least one treatment parameter can include one or more fiducials150 a, 150 b, and 150 c indicative of at least one dosage of at leastone injectable agent to be injected at at least one of the one or moreinjection needle access regions. The dosage of the injectable agent caninclude one or more units or parts thereof, one or more milliliters orparts thereof, or one or more other measures of dosage. For example, theneurotoxin onabotulinumtoxinA (BOTOX®) is typically injected in 3-5 unitincrements per injection. The dosage can also include timing andsequence of injection of the injectable agent. For example, aninjectable agent may be injected multiple times over the course ofhours, days, or weeks. For example, a treatment regimen may include twoor more injectable agents and each of two or more injectable agents maybe injected in a preferred or prescribed sequence.

In an embodiment, the one or more fiducials 150 a, 150 b, and 150 cindicative of at least one treatment parameter match a specificinjectable agent, e.g., a red fiducial for a neurotoxin, a blue fiducialfor a subcutaneous volume enhancer, and a green fiducial for a dermalfiller. In an embodiment, the one or more fiducials 150 a, 150 b, and150 c indicative of at least one treatment parameter match a dose of aspecific injectable agent, e.g., a red fiducial equals 5 units, a bluefiducial equals 10 units, and a green fiducial equals 15 units.

In some embodiments, the one or more fiducials 150 a, 150 b, and 150 cindicative of at least one treatment parameter are indicative of atleast one needle injection depth of at least one type of injectableagent to be injected at at least one of the one or more injection needleaccess regions. In some embodiments, the one or more needle injectiondepth is dependent upon the length of the injection needle. FIG. 1Billustrates a diagram of a typical injection needle 160 attached via aneedle hub 165 to a syringe 170. The length 175 of the injection needle160 or needle shank is the length of the injection needle 160 asmeasured from the needle hub 165 at the proximal end of the injectionneedle 160 to the tip of the bevel 180 at the distal end of theinjection needle 160. The bevel 180 is the slanted portion of theinjection needle 160 that creates a sharp, pointed tip. The length 175of the injection needle 160 can be measured in inches or mm. In someembodiments, the length 175 of the injection needle 160 can vary fromabout 4 mm ( 5/32 inches) to about 12.7 mm (½ inches). Injection needlesof shorter or longer length, e.g., up to about 50 mm (2 inches) or morecan also be contemplated for use with the wearable injection guide.

In some embodiments, the rigid material 110 of the wearable injectionguide includes a needle depth-limiting surface proximate to or at leastpartially coincident with at least one of the one or more injectionneedle access regions. In some embodiments, the needle depth-limitingsurface is defined as the distance or thickness between an inner andouter surface of the rigid material of the wearable injection guide. Forexample, the rigid material can have a thickness that limits the depthto which an injection needle can be injected. For example, a rigidmaterial that is 2 mm thick at an injection needle access region willallow a 4 mm needle to reach, at most, an injection depth of 2 mm. Insome embodiments, the rigid material can have a uniform thicknessthroughout the wearable injection guide, including at the one or moreinjection needle access regions. In some embodiments, the rigid materialmay vary in thickness and may vary in thickness specifically at the oneor more injection needle access regions. For example, the thickness maybe 3 mm at one injection needle access region and 2 mm at a secondinjection needle access region, thereby permitting a 4 mm injectionneedle to penetrate the skin no more than 1 mm and 2 mm at therespective injection sites. The wearable injection guide 100 can vary inthickness across a single surface according to design and purpose, andcan range from about 0.1 mm to about 25 mm or more.

In some embodiments, the depth to which the injection needle penetratesin to the underlying tissue of the body region of an individual isdependent upon whether or not the injection needle is inserted to a stoppoint defined by the needle hub bumping up against the outer surface ofthe wearable injection guide. In the instance where the injection needleis inserted all the way to a stop point, the depth to which theinjection needle penetrates into the underlying tissue of the bodyregion will be dependent upon the thickness of the wearable injectionguide, the thickness of the injection needle access region itself,and/or the length of the injection needle. The one or more fiducials onthe wearable injection guide related to needle injection depth caninclude information related to the preferred type of needle for use at agiven injection needle access region and whether the preferred injectionneedle needs to be injected to a stop point as defined, for example, bythe needle hub.

In some embodiments, the wearable injection guide includes at least oneneedle-penetrable membrane covering at least a portion of at least onesurface of the rigid material. In some embodiments, the at least oneneedle-penetrable membrane serves as a needle-depth limiting surface,limiting the depth to which an injection needle can be inserted throughthe one or more injection needle access regions, e.g., openings in therigid material, and into the underlying tissue.

In some embodiments, the wearable injection guide 100 can be used inconjunction with one or more depth-limiting adapters. The one or moredepth-limiting adapters are configured to limit the depth to which aninjection needle can be injected into the skin tissue of an individual.In an embodiment, a depth-limiting adapter can be configured as a tubewith an inner diameter sufficient to accommodate passage of an injectionneedle of a specific gauge and a length sufficient to limit the depth towhich an injection needle can be injected into the underlying tissue ofthe body region of the individual. The inner diameter can range fromabout 5 mm to about 0.2 mm. In an embodiment, the inner diameter of thedepth-limiting adaptor can range from about 0.8 mm to about 0.3 mm toaccommodate an injection needle ranging in size from 21 to 32 gauge,which are injection needle gauges commonly used for injecting agentstissue. The inner diameter of the depth-limiting adapter can also besufficiently small to allow insertion of the injection needle up to butnot including the hub of the needle. For example, a depth-limitingadapter of about 5 mm in length would allow a needle of about 12.7 mm inlength to be injected to a stop point defined by the needle hub and toreach a skin depth of about 7.7 mm if used alone or to a skin depth ofabout 4.7 mm if used in conjunction with a wearable injection guide witha thickness of about 3 mm. In some embodiments, the one or moredepth-limiting adapters can have a shape, e.g., a diameter, tofacilitate at least partial insertion of the depth-limiting adapter intoat least one of the one or more injection needle access regions. Forexample, the depth-limiting adapter can be a hollow cylinder with anouter diameter that is configured for insertion into an injection needleaccess region that is an opening defined by the rigid material of thewearable injection guide. The one or more depth-limiting adapters canrange in length from about 1 mm to about 25 mm or more. In someembodiments, the depth-limiting adapter is telescoping, allowing foradjustment of the length of the depth-limiting adapter and consequentlythe depth to which an injection needle can be injected into anunderlying tissue.

In some embodiments, the one or more injection needle access regions 130arranged in a treatment pattern 140 are incorporated into the wearableinjection guide 100 at the time of manufacture. In some embodiments, theone or more fiducials, e.g., 150 a, 150 b, and 150 c, indicative of atleast one treatment parameter specific to the individual are alsoincorporated into the wearable injection guide 100 at the time ofmanufacture. For example, the digitized image of the body region, e.g.,an individual's face 120, can be incorporated into a digitally renderedmodel of a wearable injection guide intended for three-dimensionalprinting and can include the one or more injection needle accessregions, indicating the injection sites as well as the one or morefiducials e.g., 150 a, 150 b, and 150 c, indicative of the at least onetreatment parameter.

In some embodiments, the one or more injection needle access regions 130are incorporated into the wearable injection guide 100 at the time ofmanufacture, but the one or more fiducials indicative of at least onetreatment parameter, e.g., the actual sites and/or treatment parameterintended for injection on a given treatment day, can be marked on thewearable injection guide after the wearable injection guide has beenmanufactured. For example, the treating physician, other practitioner,or the individual themselves (in the case of self-injection) can placethe one or more fiducials indicative of at least one treatment parameteron the wearable injection guide using a pen or other marking device atthe prescribed injection sites.

In some embodiments, the wearable injection guide is used by a physicianor other practitioner to guide injection of injectable agents into apatient. In some embodiments, the wearable injection guide is used by anindividual to guide self-injection of an injectable agent.

The wearable injection guide can be configured for placement on a bodyregion of the individual including, but not limited to, the face, thetorso, the abdomen, the neck, the head, the upper extremities, the lowerextremities, the buttocks, or any other body region of the individualaccessible to injection. FIG. 2 is a non-limiting embodiment thatillustrates a wearable injection guide 200 for use on body region 210 onthe lower abdomen of an individual. The wearable injection guide 200includes one or more injection needle access regions 230. The one ormore injection needle access regions 230 are annotated with one or morefiducials 240 a or 240 b indicative of at least one treatment parameterand can include one or more of colors, numbers, letters, shapes,crosshairs, or combinations thereof. In some embodiments, the one ormore injection needle access regions 230 can be annotated with one ormore fiducials 240 a that are positioned proximal to the one or moreinjection needle access regions 230. In some embodiments, the one ormore injection needle access regions 230 can be annotated with one ormore fiducials 240 b that are coincident with or superimposed on the oneor more injection needle access regions 230. The one or more treatmentparameters indicated by the one or more fiducials can include one ormore of a type of injectable agent, a dosage of the injectable agentand/or a needle injection depth.

In some embodiments the wearable injection guide 200 is configured foruse by the individual for self-injection of an injectable agent.Non-limiting examples of injectable agents for self-injection includeantibiotics, insulin, fertility hormones (e.g., FSH, ganirelix,cetrotide, Lupron, HCG), immunomodulators (e.g., etanercept), glatiramer(injected daily to treat multiple sclerosis), teriparatide (injecteddaily to treat osteoporosis), enoxaparin (injected daily to treat deepvein thrombosis), vitamins (e.g., vitamin B 12). In some embodiments,the wearable injection guide 200 may have an orientation as indicated byan orientation indicium 220 that allows an individual to decipher theone or more fiducials 240 a and 240 b, e.g., letters and/or numbers, onthe wearable injection guide 200 when it is deployed on the individual'sabdomen 210 but would otherwise appear upside-down to another personviewing the wearable injection guide 200 on said individual's abdomen210.

FIGS. 3A and 3B depict further aspects of some embodiments of a wearableinjection guide including one or more injection needle access regionsthat allow one or more injection needles to pass through the rigidmaterial at various angles and into the underlying tissue of the bodyregion of the individual. FIG. 3A is a cross-sectional view throughwearable injection guide 300 and depicts an injection needle 340 passingthrough the rigid material 310 of the wearable injection guide 300 atvarious angles and into the underlying tissue of the body region 320 ofan individual. In some embodiments, the one or more injection needleaccess regions 330 a transect the rigid material 310 at an angle of 90degrees relative to an adjacent surface of the rigid material 310. Assuch, injection needle 340 is able to pass through the wearableinjection guide 300 and into the underlying tissue of the body region320 of the individual at a 90 degree angle relative to the surface ofthe wearable injection guide 300. In this manner, the injection needle340 can be injected straight into the underlying tissue of the bodyregion 320 of an individual to a preferred depth. In some embodiments,the one or more injection needle access regions transect the rigidmaterial at an angle of less than 90 degrees relative to an adjacentsurface of the rigid material. For example, one or more injection needleaccess regions 330 b can be configured to allow an injection needle 340to pass through the wearable injection guide 300 and into an underlyingtissue of the body region 320 of the individual at an angle of about 60degrees. In another example, one or more injection needle access regions330 c can be configured to allow an injection needle 340 to pass throughthe wearable injection guide 300 and into an underlying tissue of thebody region 320 of the individual at an angle of about 30 degrees. Theone or more injection needle access regions, e.g., one or more areas ofthe rigid material 310 defining one or more openings, one or moreportions of the rigid material having a reduced hardness, and/or one ormore portions of the rigid material having a reduced thickness, can beconfigured to allow an injection needle 340 to pass through the wearableinjection guide 300 and into the underlying tissue of the body region320 of the individual at an angle ranging from greater than 0 degreesand less than or equal to 90 degrees.

The angle of the one or more injection needle access regions, e.g., 330a, 330 b and/or 330 c, through the rigid material 310 of the wearableinjection guide 300 can be dependent on the injectable agent and thedesired depth of the needle injection into the underlying tissue of thebody region 320 of the individual and the desired pattern of injection.For example, as illustrated in FIG. 3B, injections into the muscle,i.e., intramuscular injection, may be done with an injection needle 340a through the wearable injection guide 300 at a 90 degree angle;injections into the subcutis, i.e, subcutaneous injection, may be donewith an injection needle 340 b through the wearable injection guide 300at a 45 degree angle; and injections into the epidermis or dermis may bedone with an injection needle 340 c through the wearable injection guide300 at a 10 to 15 degree angle.

In some embodiments, the wearable injection guide comprises a rigidneedle-penetrable material having an inner surface and an outer surface,the inner surface having form-fitting contours substantially conformingto the topography of a body region of an individual and the outersurface having one or more fiducials indicative of at least onetreatment parameter.

FIG. 4 illustrates a non-limiting embodiment of a wearable injectionguide 400 deployed on the body region 410 of an individual. The wearableinjection guide 400 formed from one or more rigid needle-penetrablematerials has an outer surface 420 including one or more fiducials 430indicative of at least one treatment parameter. The one or morefiducials indicative of at least one treatment parameter include one ormore shapes, colors, numbers, letters, crosshairs, or combinationsthereof. Non-limiting examples of the at least one treatment parameterinclude at least one type of injectable agent to be injected at said oneor more fiducials, at least one dosage amount of an injectable agent tobe injected at said one or more fiducials, at least one angle ofinjection of the injection needle to be injected at said one or morefiducials, or at least one needle injection depth of at least one typeof injectable agent to be injected at said one or more fiducials. Insome embodiments, the one or more treatment parameters are part of atreatment regimen. In some embodiments, the treatment regimen isspecific to the individual. In some embodiments, at least a portion ofthe rigid needle-penetrable material is transparent at at least one of alocation proximal to or coincident with the one or more fiducials. Forexample, the rigid material may be transparent in a portion of thewearable injection guide including one or more fiducials such that anunderlying treatment area on the body region of the individual isvisible through the wearable injection guide.

Returning to FIG. 4, in some embodiments, the one or more fiducials 430indicative of at least one treatment parameter are arranged in atreatment pattern 440 on the outer surface 420 of the wearable injectionguide 400. The one or more fiducials arranged in a treatment pattern caninclude one or more shapes, colors, numbers, letters, crosshairs, orcombinations thereof arranged in a treatment pattern. FIG. 4 illustratesvarious embodiments of one or more fiducials arranged in a treatmentpattern including treatment pattern 440 a including one or more numbers,treatment pattern 440 b including one or more shapes, treatment pattern440 c including one or more letters, treatment pattern 440 d includingone or more colors, or treatment pattern 440 e including combinations ofnumbers, shapes, letters, and colors.

In some embodiments, the one or more fiducials 430 are merely indicativeof where an injection needle should be inserted through the wearableinjection guide. For example, the wearable injection guide may bedesigned for use with one specific injectable agent with one specificinjection dose and one specific needle depth such that the only variableindicated by the one or more fiducials, e.g., crosshairs, is the actualsite of injection. In some embodiments, any given injection site mayinclude a first fiducial indicating the injection site and at least onesecond fiducial indicating one or more treatment parameters for saidassociated injection site. In some embodiments, a first set of fiducialsare used to indicate the treatment parameters while a second set offiducials are used to indicate the injection sites, the first set offiducials not necessarily proximal to or coincident with the injectionsites. For example, the first set of fiducials may be distributed alongan edge of the wearable injection guide and providing treatmentparameter information, e.g., injection information, for a second set offiducials arranged in treatment pattern on the wearable injection guide.

In some embodiments, the one or more fiducials 430 are indicative of thepresence of one or more agents incorporated into wearable injectionguide 400, either in or on the inner surface of the wearable injectionguide 400 or in at least one agent-containing reservoir associated withthe wearable injection guide. The one or more agents can include one ormore analgesics, disinfectants, antiseptics, sterilants, therapeuticagents or combinations thereof.

In some embodiments, the one or more fiducials 430 indicative of atleast one treatment parameter and arranged in a treatment pattern 440are arranged in one or more predetermined treatment patterns. Forexample, the treatment pattern of the one or more fiducials may bepredetermined depending upon the type of injectable agent and/or thecondition being treated. For example, cosmetic treatment of a portion ofthe face, e.g., the glabella frown lines, may follow a predeterminedpattern of injection sites. In some embodiments, the predeterminedtreatment pattern of one or more fiducials is provided by a computingdevice that stores treatment patterns specific for a condition, specificfor an injectable agent, and/or specific for the individual. Forexample, one or more digitally rendered fiducials indicative of the oneor more fiducials can be incorporated into a digitally rendered model ofthe wearable injection guide in a predetermined treatment pattern andsubsequently incorporated into a formed wearable injection guide duringa manufacturing process, e.g., three-dimensional printing.

In some embodiments, the one or more fiducials 430 can be placed ontowearable injection guide 400 by a physician or other practitioner atsome point after the guide is formed but prior to treatment. In anembodiment, the one or more fiducials can be manually placed on thewearable injection guide by an individual at some point after the guideis formed but prior to self-injection treatment. The one or morefiducials are placed onto the wearable injection guide based on thedesired treatment parameters. In some embodiments the one or morefiducials are placed on the wearable injection guide by the physician,other practitioner, or the individual in a predetermined treatmentpattern based on one or more of the condition, the injectable agent orspecific topography and/or anatomical features of the individual. Inthis manner, multiple personalized wearable injection guides can begenerated at one time for a particular individual and the treatmentoptions for a given treatment period, e.g., a given treatment day oroffice visit, can be marked on the wearable injection guide at the timeof treatment, providing flexibility in the treatment regimen.

In some embodiments, the arrangement of one or more fiducials 430 in atreatment pattern 440 on the wearable injection guide 400 is dependentupon the specific needs of the individual. In some embodiments, the oneor more fiducials are arranged in a treatment pattern that coincideswith a treatment area on the body region of the individual. For example,in the case of a wearable injection guide 400 deployed on anindividual's face, the arrangement of the one or more fiducials 430 in atreatment pattern 440 can include one or more fiducials 430 situatedover or proximal to one or more lines, wrinkles, folds, or pouches inneed of treatment on the body region 410 of the individual. For example,a wearable injection guide can include one or more fiducials arranged ina treatment pattern which when deployed on the individual's face aresituated over or proximal to lines, wrinkles, folds, or pouchesassociated with a forehead, a glabella, a periorbital region, anauricular region, an ear, a lip, a cheek, a nasolabial fold, a labialregion, a perilabial region, a sublabial region, a labiomental crease,or a neck region of the individual.

In some embodiments, the treatment pattern 440 includes one or morefiducials 430 situated over one or more muscles associated with creatinglines and/or wrinkles on the body region 410 of the individual. Forexample, in treating an individual's face, the wearable injection guidecan include one or more fiducials arranged in a treatment pattern thatare situated over or proximal to one or more of the occipito-frontalismuscle of the forehead for treatment of horizontal forehead wrinkles;the procerus muscle between the eyebrows for treatment of horizontalwrinkling above the bridge of the nose; the corrugators muscle fortreatment of the “11” wrinkles that appear between the eyebrows orglabella during an angry facial expression; the orbicularis oculimuscles around the eyes for the treatment of “crow's feet;” the nasalismuscles of the nose for the treatment of “bunny lines” along the side ofthe nose; the orbicularis oris muscles around the lips for the treatmentof radial pucker lines on the lips; and the depressor anguli orismuscles under the lips for the treatment of down turning of the cornersof the mouth while frowning.

In some embodiments, the treatment pattern 440 can include one or morefiducials 430 arranged in a treatment pattern so as to avoid portions ofthe underlying tissue of the body region that might be contraindicatedfor administration of the injectable agent. For example, the one or morefiducials on the wearable injection guide may be arranged so as to avoidinjection of an injectable agent into an underlying blood vessel. Othernon-limiting examples of contraindicated injection sites include areasof infection, skin disease or inflammation (unless the injectable agentis being used to treat said conditions) or areas too close to the orbits(to prevent ptosis). In another example, the one or more fiducials maybe arranged in a treatment pattern so as to avoid injection of aninjectable agent into a site that has been previously injected.

FIGS. 5A-5C illustrate further non-limiting embodiments of a wearableinjection guide. FIGS. 5A, 5B, and 5C are cross-sectional views ofwearable injection guide 500 deployed on body region 510 of anindividual. The wearable injection guide 500 includes an inner surface520 and an outer surface 530 separated by a rigid needle-penetrablematerial 540. The rigid needle-penetrable material 540 can include oneor more of acrylic, nylon, plastic, ceramic, resin, rubber, epoxy,thermoplastic, photopolymer, polyurethane, latex, or silicone. In someembodiments, at least a portion of the rigid needle-penetrable material540 is transparent.

The inner surface 520 of wearable injection guide 500 includesform-fitting contours substantially conforming to a topography of a bodyregion 510 of an individual. In some embodiments, the inner surface 520includes form-fitting contours substantially conforming to thetopography of one or more of the individual's facial region, torsoregion, abdominal region, head region, neck region, upper extremity,lower extremity, buttocks, or any other body region accessible forinjection. In an embodiment, the inner surface 520 can includeform-fitting contours substantially conforming to the topography of oneor more regions of the individual's face including but not limited to anindividual's forehead region, eye region, cheek region, mouth region, orcombinations thereof. The portion of the body region 510 covered by thewearable injection guide 500 can be dependent upon the desired treatmentlocation. For example, the wearable injection guide 500 can include aninner surface 520 with form-fitting contours substantially conforming tothe combined forehead and eye regions of the individual for treatment oflines and/or wrinkles around the forehead and eyes. In another example,the wearable injection guide 500 can include an inner surface 520 withform-fitting contours substantially conforming to a body regionassociated with an individual's upper thigh or lower abdominal region.

The outer surface 530 of the wearable injection guide 500 is configuredto limit the depth to which an injection needle is capable ofpenetrating the underlying tissue of the body region 510. In someembodiments, the outer surface of the rigid needle-penetrable materialincludes an outer contour with one or more portions separated from theinner surface of the rigid needle-penetrable material by at least oneneedle depth-limiting distance. In some embodiments, theneedle-depth-limiting distance is about 0.5 mm to about 25 mm. In someembodiments, a needle depth-limiting distance is equivalent to athickness of the rigid material of the wearable injection guide. Forexample, outer surface 530 has a contour defined by one or more needledepth-limiting distance 550 of rigid needle-penetrable material 540separating the outer surface 530 from the inner surface 520 of thewearable injection guide 500. In some embodiments, as illustrated inFIG. 5A, the outer surface 530 has a uniform contour defined by needledepth-limiting distance 550 of rigid needle-penetrable material 540separating the outer surface 530 from the inner surface 520 of thewearable injection guide 500. Needle depth-limiting distance 550 of therigid needle-penetrable material 540 is uniform across the entirety ofthe wearable injection guide 500. Needle depth-limiting distance 550 canbe based on the length of needle used for the injection. Alternatively,needle depth-limiting distance 550 can be based on how deep into theunderlying tissue of the body region 510 of the individual the injectionneedle is intended to go. For example, needle depth-limiting distance550 can be uniformly about 0.5 mm to about 12.5 mm across the entiretyof the wearable injection guide 500. Needle depth-limiting distance 550of the rigid needle-penetrable material 540 can be a thickness such thatthe one or more injection needles used to inject one or more injectableagents will reach the appropriate tissue depth when inserted through thewearable injection guide 500 as far as they will go. For example, asshown in the embodiment of FIG. 5A, a first needle with a first needlelength 560 a penetrates through the outer surface 530 of the rigidneedle-penetrable material 540 into the underlying tissue of the bodyregion 510 to a first depth 570 a while a second needle with a secondneedle length 560 b penetrates through the outer surface 530 of therigid needle-penetrable material 540 into the underlying tissue of thebody region 510 to a second depth 570 b.

In some embodiments, the outer surface 530 of the wearable injectionguide 500 includes one or more fiducials indicating whether the firstneedle with the first needle length 560 a or the second needle with thesecond needle length 560 b should be used at a given site on thewearable injection guide 500.

In some embodiments, as illustrated in FIG. 5B, the outer surface 530has a varied contour defined by more than needle depth-limiting distance550 of rigid needle-penetrable material 540 separating the outer surface530 from the inner surface 520 of the wearable injection guide 500. Forexample, the outer surface 530 and the inner surface 520 of the wearableinjection guide 500 can be separated by at least one first needledepth-limiting distance 550 a and at least one second needledepth-limiting distance 550 b. The proportion of the rigidneedle-penetrable material with at least one first needle depth-limitingdistance 550 a and at least one second thickness 550 b can vary acrossthe entirety of the wearable injection guide 500. The at least one firstneedle depth-limiting distance 550 a and at least one second needledepth-limiting distance 550 b can be based on the length of injectionneedle used for the injection. The at least one first needledepth-limiting distance 550 a and at least one second needledepth-limiting distance 550 b can be based on how deep the injectionneedle is intended to be injected into the underlying tissue of the bodyregion 510. For example, the at least one first needle depth-limitingdistance 550 a and the at least one second needle depth-limitingdistance 550 b can vary from about 0.5 mm to about 12.5 mm across theentirety of the wearable injection guide 500. The at least one firstneedle depth-limiting distance 550 a and the at least one second needledepth-limiting distance 550 b of the rigid needle-penetrable material540 can vary such that the one or more injection needles used to injectthe one or more injectable agents will reach the appropriate tissuedepth when they are inserted as far as they will go. For example, asillustrated in the embodiment of FIG. 5B, needle 560 penetrates a firstportion of the outer surface 530 with a first needle depth-limitingdistance 550 a and through the rigid needle-penetrable material 540 intothe underlying tissue of the body region 510 to a first depth 570 awhile needle 560 penetrates a second portion of the outer surface 530with a second needle depth-limiting distance 550 b and through the rigidneedle-penetrable material 540 into the underlying tissue of the bodyregion 510 to a second depth 570 b.

In some embodiments, as illustrated in FIG. 5B, the injection needle mayreach a stop point when the needle hub 580 comes in contact with theouter surface 530 of the wearable injection guide 500. The needle hub580 (or syringe adapter) can be located at the proximal end of theinjection needle 560 (also see FIG. 1B) and used to attach the injectionneedle to the barrel of a syringe by means of a press-fit or a twist-onmechanism.

In some embodiments, as illustrated in FIG. 5C, the outer surface 530 ofthe wearable injection guide 500 can include a downward tapered accesssurface 590. In an embodiment, the downward tapered access surface 590can be used to help direct an injection needle 560 towards the center ofan injection site defined by the one or more fiducials. In someembodiments, the downward tapered access surface 590 of the outersurface 530 accommodates the injection needle 560 to a stop pointdependent upon the size of the needle hub 580 or the diameter of thesyringe 585, allowing the injection needle 560 to penetrate theunderlying tissue of the body region 510 to a specific depth 570.

In some embodiments, at least one of the one or more fiducialsindicative of a treatment parameter is placed so as to coincide with oneor more portions of the outer surface of the wearable injection guide,e.g., at one or more of at least a first needle depth-limiting distanceor one or more of at least second needle depth-limiting distance betweenthe outer and inner surfaces of the rigid needle-penetrable material.

In some embodiments, the depth to which an injection needle is injectedthrough the wearable injection guide and into the underlying tissue ofthe body region is dependent upon both the specific features of the bodyregion and on the injectable agent being injected at said injectionsite. For example, specific features of an individual's face coulddictate injection depth, including the severity of lines or wrinklesand/or the thickness of the tissue layers at any given injection site.Dermal thickness in most areas of the face is less than 1 mm thick. Forexample, the thickness of the epidermis (top layer of skin) is about0.05 mm near the eye lids while the epidermis on the rest of the face ison average of about 0.1 to 0.3 mm. In addition, the injection depth maybe dependent upon the age of the individual, as the tissue layers thinwith increasing age. Furthermore the depth may be dependent upon theinjectable agent being injected and the type of tissue into which saidinjectable agent is injected. For example, a dermal filler, e.g.,hyaluronic acid, can be injected into the superficial papillary dermisfor treating fine wrinkles and scars, but is injected deeper into thereticular dermis for deeper lines. Similarly, bovine or human collagenfiller is injected into the papillary and middle dermis to treat finelines and wrinkles in, e.g., the perioral area (e.g., the cutaneousupper lip), the periorbital area, and glabella of the face.Polymethylmethacrylate microspheres filler can be injected subdermally,e.g., into the border of the dermis and subcutaneous fat, to treatrhytids and scars. The botulinum neurotoxin, for example, is injected toabout 2 to 3 mm below the surface of the skin.

In some embodiments, the at least one injectable agent is injected intothe muscle of the underlying tissue of the body region of theindividual. Non-limiting examples of injectable agents that are injectedintramuscularly include neurotoxins, codeine, morphine, methotrexate,metoclopramide, olanzapine, streptomycin, diazepam, prednisone,penicillin, interferon beta-1a, testosterone, estradiol, dimercaprol,ketamine, Lupron, maloxone, quinine, vitamin B12, Gardasil, hepatitis Avaccine, rabies vaccine, and influenza vaccine.

In some embodiments, the at least one injectable agent is injectedsubcutaneously. Non-limiting examples of injectable agents that areinjected subcutaneously include insulin, morphine, diacetylmorphine, andgoserelin.

In some embodiments, the at least one injectable agent is injectedintradermally. Non-limiting examples of injectable agents that areinjected intradermally include influenza vaccines, tuberculosis skintests, and allergy shots.

In some embodiments, the wearable injection guide can further includeone or more agents dispensed to the individual's skin, exemplary aspectsof which are illustrated in FIGS. 6A-6D. FIGS. 6A-6D illustrate across-sectional view of a wearable injection guide 600 that includes aninner surface 620 having form-fitting contours substantially conformingto the topography of a body region 610 of an individual and an outersurface 630. FIG. 6A illustrates a cross-sectional view of an embodimentof wearable injection guide 600 in which the inner surface 620 of thewearable injection guide 600 is coated or impregnated with one or moreagents 650 capable of dispersing from the inner surface 620 to anunderlying tissue of the body region 610. In some embodiments, the oneor more agents 650 are added as a thin coating over the inner surface620 of the wearable injection guide 600 either at the time ofmanufacture or just prior to use. In some embodiments, the one or moreagents 650 are impregnated into an inner surface 620 of wearableinjection guide 600 that is highly porous. In some embodiments, the oneor more agents 650 are released from the inner surface 620 of thewearable injection guide 600 in a time-dependent manner, being fullydispersed over the course of a treatment period. For example, the one ormore agents 650 incorporated into a porous inner surface 620 of awearable injection guide 600 may leach out from the inner surface andonto the underlying tissue of the body region at a rate dependent uponthe porosity of the wearable injection guide, with more rapid releasefrom larger pores relative to release from smaller pores. In someembodiments, the one or more agents 650 can be dispersed from the innersurface 620 of the wearable injection guide 600 over the course of atreatment period lasting from about 5 minutes to about 120 minutes,e.g., the time spent in a physician's or other practitioner's officereceiving treatment. It is also contemplated that the treatment timecould be shorter than 5 minutes or longer than 120 minutes and takeplace in the context of self-treatment with an injectable agent.

In some embodiments, release of the one or more agents 650 from theinner surface 620 of the wearable injection guide 600 is initiated byone or more stimulus such as, for example, exposure to light, skin pH,and/or temperature. For example, the one or more agents can be releasedfrom the inner surface 620 of wearable injection guide 600 in responseto exposure to normal skin surface temperature, e.g., about 31 degreesCentigrade to about 35° degrees Centigrade. For example, the one or moreagents can be released from the inner surface 620 of wearable injectionguide 600 in response to heating the wearable injection guide prior todeployment onto the individual. Rozman et al. describe a non-limitingexample of a temperature-sensitive microemulsion for delivery of anagent (see, e.g., Rozman, et al., AAPS PharmSciTech (2009) 10:54-61,which is incorporated herein by reference). For example, the one or moreagents can be released from the inner surface 620 of wearable injectionguide 600 in response to exposure to normal skin pH, e.g., about pH 5.4.Non-limiting examples of pH sensitive delivery systems are described inSlepushkin et al., J. Biol. Chem. (1997) 272:2382-2388, which isincorporated herein by reference. In some embodiments, the one or moreagents can be released from the inner surface of the wearable injectionin response to exposure to ambient light or other light source.Non-limiting examples of light-triggered delivery systems are describedin Yavlovich et al., Mol. Membr. Biol. (2010) 27:364-381, which isincorporated herein by reference. In some embodiments, the one or moreagents 650 are released from the inner surface 620 of the wearableinjection guide 600 immediately after removal of a cover that otherwiseprevents premature release of the one or more agents 650.

FIG. 6B illustrates a cross-sectional view of an embodiment of awearable injection guide 600 that includes at least one agent-containingreservoir 660 containing one or more agents 650. The at least oneagent-containing reservoir 660 is preferably positioned on or near theinner surface 620 of the wearable injection guide 600 and in closeproximity to the surface of a body region 610. The at least oneagent-containing reservoir 660 can include one or more agents 650configured to be released from the at least one agent-containingreservoir 660 and on to the underlying surface of a body region 610. Insome embodiments, the one or more agents 650 are released from the atleast one agent-containing reservoir 660 prior to injection of the oneor more needles into the underlying tissue of the body region 610. Forexample, the one or more agents 650 can include one or more analgesicagents released from the at least one agent-containing reservoir 660prior to injection of the one or more needles to mitigate any painassociated with needle injection. The agent-containing reservoir mayhave a seal, e.g., an adhesive film or tape, which is removed just priorto deploying the wearable injection guide, allowing for release of theone or more agents. In some embodiments, the one or more agents 650 arereleased from the at least one agent-containing reservoir 660 at anytime prior, during and/or following insertion of the one or moreinjection needles through the wearable injection guide and into anunderlying tissue of the body region of the individual. The timing forrelease of the one or more agents 650 from the at least oneagent-containing reservoir 660 is dependent upon the nature of the oneor more agents 650 and the type of treatment. In some embodiments, theat least one agent-containing reservoir 660 is incorporated into therigid material at or near at least one of the one or more injectionneedle access regions. In some embodiments, the at least oneagent-containing reservoir 660 is in close proximity to the one or moreinjection needle access regions. In some embodiments, the at least oneagent-containing reservoir 660 is incorporated into at least one of theone or more injection needle access regions.

FIG. 6C illustrates a cross-sectional view of an embodiment of awearable injection guide 600 including one or more agents 650 containedin layer 605 between the inner surface 620 and the outer surface 630 ofwearable injection guide 600. Upon insertion of a needle 670 throughwearable injection guide 600, the one or more agents 650 are releasedfrom layer 605 of the wearable injection guide 600 and onto or into theunderlying tissue of body region 610. For example, the injection needlemay be coated with the agent as it passes through the wearable injectionguide, carrying the agent into the underlying tissue of the body regionduring the injection process. In this way, an analgesic or antiseptic,for example, can be released in concert with injection of one or moreneedles into the underlying tissue of the body region 610. In someembodiments, at least a portion of layer 605 between the inner surface620 and the outer surface 630 includes a single needle-penetrablereservoir containing one or more agents 650. In some embodiments, atleast a portion of layer 605 includes multiple needle-penetrablereservoirs wherein only one of the multiple needle-penetrable reservoirsis punctured at any given time during insertion of needle 670.

FIG. 6D illustrates a cross-sectional view of a wearable injection guide600 including one or more agents 650 contained within one or moreinjection needle access regions 640 of the wearable injection guide 600.The one or more agents 650 contained within the one or more injectionneedle access regions 640 are released onto or into the underlyingtissue of the body region 610 upon insertion of needle 670. In anembodiment, the one or more agents can be contained in a reservoir,e.g., a needle-penetrable bubble-like reservoir, which is inserted intothe injection needle access region following manufacture. In anembodiment, the one or more agents can be contained in a gel placed intoone or more of the injection needle access regions. The gel can include,but is not limited to, one or more of a cationic polymer, a hydrogel, ororganogel. In this way, an analgesic or antiseptic, for example, can bereleased in concert with needle injection into the underlying tissue ofthe body region 610.

In some embodiments, the one or more agents released from the wearableinjection guide include one or more analgesics for reducing painassociated with the injection treatment. Non-limiting examples ofanalgesics include lidocaine, prilocaine, tetracaine, cocaine,pramoxine, dibucaine, benzocaine, dyclonine, a NSAID, or an opiate. Forexample, lidocaine, either alone or in combination with prilocaine as aeutectic mixture (2.5% lidocaine/2.5% prilocaine) can be used to easethe acute pain of needle insertion (see, e.g., McCleane, Curr. Opin.Anesthesiol., (2010) 23:704-707; Kundu & Achar, Am. Fam. Physician(2002) 66:99-102, which are incorporated herein by reference).

In some embodiments, the at least one analgesic can include one or moreof a vapocoolant or skin refrigerant, e.g., menthol; ethyl chloride;dichlorodifluromethane mixed with trichloromonofluoromethane; orpentafluoropropane mixed with tetrafluoroethane; and the like.

In some embodiments, the one or more agents released from the wearableinjection guide include one or more of a disinfectant, antiseptic orsterilant for disinfecting the surface of the body region prior to orduring injection of the injectable agent. Non-limiting examples ofdisinfectants, antiseptics and/or sterilants include isopropanol, silvercompounds, ethanol, povidone, iodine, glutaraldehyde, formaldehyde,chlorhexidine gluconate, sodium hypochlorite, quaternary ammoniumscompounds, hydrogen peroxide, and phenols.

In some embodiments, the one or more agents released from the wearableinjection guide include one or more therapeutic agents. Non-limitingexamples of therapeutic agents include retinoids, corticosteroids,chemotherapeutics, antimicrobials (i.e., antibacterial agents, antiviralagents, or antifungal agents).

In some embodiments, the one or more agents released from the wearableinjection guide include at least one retinoid. Retinoids can be used fortreating various conditions of the skin including, but not limited to,acne, psoriasis, photodamaged skin and cancers including AIDS-relatedKaposi's sarcoma and cutaneous T-cell lymphoma. Non-limiting examples ofretinoids for topical use include alitretinoin, bexarotene, adapalene,tazarotene, and isotretinoin.

In some embodiments, the one or more agents released from the wearableinjection guide include at least one corticosteroid. Corticosteroids canbe used for treating various inflammatory dermatoses including, but notlimited to, atopic dermatitis, psoriasis, lupus erythematosus, and thelike. Non-limiting examples of corticosteroids for topical use includehydrocortisone and derivatives, betamethasone and derivatives,dexamethasone, prednisolone and derivatives, fluocinolone acetonide,fluorometholone, alclometasone dipropionate, triamcinolone acetonide,clocortolone pivalate, flumethasone pivalate, mometasone furoate,flurandrenolide, prednicarbate, fluticasone propionate, desonide,halcinonide, desoximetasone, flurandrenolide, fluocinonide, amcinonide,fluocinolone acetonide, and diflorasone diacetate.

In some embodiments, the one or more agents released from the wearableinjection guide include at least one chemotherapy agent for treating acancer or other condition the body region. Non-limiting examples ofchemotherapy agents for topical use include fluorouracil used fortreating actinic keratoses and some types of basal cell carcinomas ofthe skin. In an embodiment, the at least one chemotherapy agent includesan immunomodulator, non-limiting examples of which include imiquimod,tacrolimus and pimecrolimus. In an embodiment, the at least onechemotherapy includes at least one agent for modulating pigmentation,non-limiting examples of which include hydroquinone, monobenzene,mequinol, trioxsalen and methoxsalen.

In some embodiments, the one or more agents released from the wearableinjection guide include one or more antimicrobial agents. The one ormore antimicrobial agents can further include at least one of anantibacterial agent, antiviral agent, or antifungal agent.

In some embodiments, the one or more antimicrobial agents released fromthe wearable injection guide include at least one antibacterial agentconfigured to prevent or minimize bacterial infection on the surface ofthe body region. In some embodiments, the at least one antibacterialagent released from the wearable injection guide is configured toprevent or minimize bacterial infection associated with injecting one ormore injectable agents into the underlying tissue of the body region. Insome embodiments, the at least one antibacterial agent released fromwearable injection guide is configured to treat or prevent or minimizeother bacterial infections on the individual's skin such as thoseassociated with acne or rosacea, for example. Non-limiting examples ofantibacterial agents commonly used for topical applications includebenzoyl peroxide, sodium sulfacetamide, erythromycin, mupirocin,retapamulin, bacitracin, neomycin, polymyxin b/e, silver sulfadiazine,or tetracycline.

In some embodiments, the one or more antimicrobial agents released fromthe wearable injection guide include at least one antiviral agent toprevent or treat a viral infection. For example, the at least oneantiviral agent can be released from the wearable injection guide toprevent or treat a viral infection on the individual's face such as thatassociated with herpes simplex types 1 and 2. Non-limiting examples ofantiviral agents commonly used for topical applications includeacyclovir, docosanol, famciclovir, imiquimod, penciclovir, valacyclovir,and vidarabine.

In some embodiments, the one or more antimicrobial agents released fromthe wearable injection guide include at least one antifungal agent toprevent or treat fungal infection on the individual's skin. In someembodiments, the at least one antifungal agent is released from thewearable injection guide to prevent or treat a fungal infection on theindividual's face such as that associated with rosacea, for example.Non-limiting examples of antifungal agents commonly used for topicalapplications include amphotericin B, butaconazole, butenafine,ciclopirox olamine, clotrimazole, econazole, ketoconazole, miconazole,naftifine, natamycin, nystatin, oxiconazole, sulconazole, terbinafine,terconazole, tioconazole, tolnaftate, and metronidazole.

The one or more agents included in either at least one agent-containingreservoir or coated or impregnated on the inner surface of the wearableinjection guide can further include a formulation. In some embodiments,the one or more agents can be formulated as part of a stimulusresponsive polymer or gel, as described above herein. In someembodiments, the one or more agents can be formulated as polymers, gels,microparticles, nanoparticles, or solutions.

The wearable injection guide further includes means for immobilizing thewearable injection guide onto a body region of an individual. In someembodiments, the means for immobilizing the wearable injection guide caninclude a reversible adhesive on a surface of the rigid material of thewearable injection guide. The reversible adhesive can be incorporatedinto or released from the inner surface of the wearable injection guide.In some embodiments, the reversible adhesive can be one or more pressuresensitive adhesive, e.g., adhesive tape, applicable for skin contact.Non-limiting examples of adhesives designed for healthcare use includeany of a number of silicone-based pressure sensitive adhesives from, forexample, Dow Corning, Midland, Mich. or 3M, St. Paul, Minn.

In some embodiments, the reversible adhesive can be applied to at leasta portion of the surface of the body region of the individual prior toplacement of the wearable injection guide onto the body region. In anembodiment, the adhesive is simply a gel, e.g., a skin lotion orpetroleum jelly, which causes the wearable injection guide to stay inone place on the surface of the body region. In an embodiment, thereversible adhesive is mixed with one or more other agent, e.g., ananalgesic agent and/or an antiseptic agent.

In some embodiments, the means for immobilizing the wearable injectionguide on the body region of an individual can include one or more bodyportion-encircling piece. FIG. 7 illustrates a non-limiting example of awearable injection guide 700 strapped to a body region 710 of anindividual's face. The one or more body portion-encircling piece, e.g.,straps 705 can be secured at one or both ends to attachment sites 725associated with the wearable injection guide 700. The one or more straps705 can be secured in one or more directions around the individual'shead 715. Alternatively, the one or more straps 705 can be securedaround the ears. The one or more straps 705 can include one or more ofan elastic strap, leather strap, plastic strap or other materialsuitable for a strap. The one or more straps 705 can further include oneor more attaching devices. Non-limiting examples of attaching devicesinclude one or more buckles, snaps, buttons, or other interlockingattaching devices. In some embodiments, the one or more strapsadjustably adhere to one another using hook and loop surfaces, e.g.,Velcro®. The wearable injection guide 700 is kept immobilized on thebody region 710, allowing for insertion of one or more injection needles750 through the one or more injection needle access regions 720 and/orthe one or more fiducials 740 and into an underlying tissue of the bodyregion 710. Similar body portion-encircling pieces are contemplated forimmobilizing a wearable injection guide to other parts of anindividual's body, e.g. the torso, abdomen, head, neck, lowerextremities, upper extremities, buttocks, and/or any other body regionaccessible for injection.

The body portion-encircling piece can further include other means ofimmobilizing the wearable injection guide to the body region of theindividual such as, for example, a sleeve or a clamp. For example, thewearable injection guide may be incorporated into a sleeve that fitsover an upper or lower extremity or around the neck. In someembodiments, the wearable injection guide may be incorporated into apiece of clothing, e.g., a shirt or shorts, that allows the wearableinjection guide to be firmly kept in place on the surface of the bodyregion. For example, the wearable injection guide may include a clamp inthe shape of a “C” that fits snuggly around an upper or lower extremity.

In some embodiments, the means for immobilizing the wearable injectionguide can include a portion of the wearable injection guide that isinserted into the individual's mouth and held in place with the teeth.In some embodiments, the means for immobilizing the wearable injectionguide can include one or more prongs extending from the inner surface ofthe wearable injection guide that insert into each nostril of theindividual's nose.

In some embodiments, the wearable injection guide can further includeone or more alignment marks configured to align with one or morereference points on the body region of the individual. In someembodiments, the wearable injection guide can include one or morealignment marks configured to align with one or more reference marksplaced on a surface of the body region of the individual. For example,the one or more alignment marks may be configured to align with one ormore reference marks placed on the surface of the body region by aphysician, other practitioner or the individual. In some embodiments,the wearable injection guide can include one or more alignment marksconfigured to align with one or more topographical landmarks of the bodyregion. Examples of topographical landmarks include but are not limitedto pigmentation, a pigmented area, e.g., freckle, mole, or birthmark, askin texture pattern, a tattoo, a subsurface blood vessel, an anatomicalfeature, an eye, a nose, or lips. In some embodiments, at least aportion of the rigid material of the wearable injection guide may betransparent near the one or more alignment marks to facilitate alignmentof the alignment marks with one or more underlying reference points onthe body region.

In some embodiments, the wearable injection guide can further include abarcode or radiofrequency identification tag for verifying that a givenwearable injection guide is suitable for a given individual. Forexample, a barcode specific for a given individual may be placed on thewearable injection guide either during or after manufacturing and usedto verify who the wearable injection guide was designed and manufacturedfor. Similarly, a radiofrequency identification tag may be placed on thewearable injection guide following manufacture and used for verifyingappropriate use with a given individual.

The wearable injection guide can further include a thermal-regulatingmechanism. The thermal-regulating mechanism can be used to alter thetemperature of the wearable injection guide to a temperature above orbelow about 98.6 degrees Fahrenheit (° F.) (37 degrees centigrade (°C.)).

In some embodiments, the thermal-regulating mechanism is a coolingmechanism configured to reduce the temperature of the wearable injectionguide to a temperature below about 98.6° F. (37° C.) or normal bodytemperature. The cooling mechanism can be configured to reduce painduring needle injection and/or to prevent potential swelling followingneedle injection. In an embodiment, the wearable injection guide caninclude a material having a relatively high heat capacity, e.g., aceramic material or a gel, and may not need a separate coolingmechanism. For example, following refrigeration, the wearable injectionguide containing or formed from a high heat capacity material canmaintain a cool temperature while in contact with the body region for anextended period of time. In some embodiments, the wearable injectionguide is cooled by placing the wearable injection guide in a coolingdevice prior to placement on a body region of an individual. Forexample, the wearable injection guide can be stored in a cooling deviceuntil use. Alternatively, the wearable injection guide can be placedinto the cooling device just prior to use for a sufficient time to coolthe wearable injection guide to an appropriate temperature. The coolingtemperature can be about 10° C. to about 0° C. It is understood that thecooling temperature can fall outside this range, but is contemplated tobe sufficiently cool enough to reduce pain and swelling but not so coldas to be painful or damaging to the underlying tissue of the bodyregion. Non-limiting examples of cooling devices for this purposeinclude a refrigerator, a freezer, or an ice bath.

In some embodiments, the wearable injection guide is cooled byincorporating a cooling mechanism directly into and/or on the wearableinjection guide. In an embodiment, the cooling mechanism can include achemical endothermic reaction using, for example, water and ammoniumnitrate. For example, the components of a chemical endothermic reactioncan be included in or on the inner surface of the wearable injectionguide and activated upon removal of the wearable injection guide from aprotective wrap. In an embodiment, the cooling mechanism can includethermoelectric cooling with, for example, a Peltier cooling device.Components of a Peltier cooling device can be incorporated into theinner surface of the wearable injection guide.

In some embodiments, the thermal-regulating mechanism is a heatingmechanism configured to raise the temperature of the wearable injectionguide to a temperature above about 98.6° F. (37° C.). The heatingmechanism can be configured to increase vasodilation and/or circulationin the underlying tissue covered by the wearable injection guide priorto, during, and/or after injection of an injectable agent. In anembodiment, the wearable injection guide can include a material having arelatively high heat capacity, e.g., a ceramic material, and may notneed a separate heating mechanism. For example, following heating in awarming oven, the wearable injection guide containing or made from ahigh heat capacity material can maintain a warm temperature while incontact with the body region for an extended period of time. In someembodiments, the wearable injection guide is warmed by heating thewearable injection guide in a heating device prior to placement onto abody region of an individual. For example, the wearable injection guidecan be stored in a heating device until use. Alternatively, the wearableinjection guide can be placed into the heating device just prior to usefor a sufficient time to heat the wearable injection guide to anappropriate temperature. The heating temperature can be about 40° C. toabout 45° C. It is understood that the heating temperature can falloutside this range, but is contemplated to be sufficiently hot enough toincrease circulation but not so hot as to be painful or damaging to theunderlying tissue of the body region. Non-limiting examples of heatingdevices for this purpose include a warming oven, a microwave, or hotwater bath.

In some embodiments, the wearable injection guide is heated byincorporating a heating mechanism directly into and/or on the wearableinjection guide. In an embodiment, the heating mechanism can include achemical exothermic reaction using, for example, components of anair-activated, iron-based warmer including a combination of cellulose,iron, activated carbon, vermiculite and salt. For example, thecomponents of a chemical exothermic reaction can be included in or onthe inner surface of the wearable injection guide and activated uponremoval of the wearable injection guide from a protective wrap. In anembodiment, the heating mechanism can include thermoelectric heatingwith, for example, a Peltier heating device. Components of a Peltierheating device can be incorporated into the inner surface of thewearable injection guide.

In some embodiments, a wearable injection guide includes a rigidmaterial substantially impenetrable to an injection needle, the rigidmaterial including one or more injection needle access regions arrangedin a treatment pattern, the one or more injection needle access regionsincluding one or more activatable injection event indicators. The one ormore activatable injection event indicators are configured to allow theuser of the wearable injection guide to determine which of the injectionneedle access regions have been previously used for insertion of aninjection needle and consequently which portions of the underlying bodyregion have previously been injected. In addition, the one or moreactivatable injection event indicators are configured to allow the userof the wearable injection guide to determine how many previousinjections have been completed and where. For example, the activatableinjection event indicators can indicate where insulin has previouslybeen injected into the lower abdomen or the upper thigh. Repeatedlyinjecting insulin near the same place can lead to hard lumps or extrafatty deposits, and as such should be avoided. In some embodiments, theone or more activatable injection event indicators can include one ormore pressure sensitive materials, e.g., one or more pressure sensitivedyes. In some embodiments, the one or more activatable injection eventindicators can include one or more flowable materials, e.g., dyes,released upon penetration of an injection needle through the wearableinjection guide. In some embodiments, the one or more activatableinjection event indicators can include one or more materials activatedby exposure to air, e.g., exposure to oxygen or moisture in theatmosphere.

FIG. 8 illustrates an embodiment of a wearable injection guide with oneor more activatable injection event indicators. The wearable injectionguide 800 comprises rigid material 810 deployed on a body region 820 ofan individual. The rigid material 810 of wearable injection guide 800includes one or more injection needle access regions 830. The one ormore injection needle access regions 830 include an activatableinjection event indicator in a first state 840 a or in a second state840 b. In some embodiments, the one or more activatable injection eventindicators include one or more materials stored in a needle-penetrablereservoir incorporated into a least one of the one or more injectionneedle access regions. The one or more materials stored in theneedle-penetrable reservoir can include, but are not limited to, one ormore flowable dyes, one or more of an oxygen sensitive, or one or moreof a moisture sensitive dye.

In some embodiments, an activatable injection event indicator in a firststate 840 a has a first color and the activatable injection eventindicator in a second state 840 b has a second color. The transitionfrom the first state 840 a to the second state 840 b can be triggered byinsertion of an injection needle through the injection needle accessregion 830, resulting in a color change detectable by the user. In someembodiments, the transition from the first state 840 a to the secondstate 840 b is triggered by releasing one or more material from theinjection needle access region 830. In some embodiments, the one or morematerial released from the injection needle access region is a flowabledye that either flows away from the injection needle access region andleaving it “colorless” or stains an otherwise colorless injection needleaccess region. In some embodiments, the one or more material releasedfrom the injection needle access region changes color in response toair, e.g., in response to oxygen or moisture in the atmosphere.Non-limiting examples of dyes or other materials that change color inresponse to oxygen include materials including methylene blue (see,e.g., U.S. Pat. No. 4,526,752, which is incorporated herein byreference). Non-limiting examples of dyes or other materials that changecolor in response to moisture include materials including cobalt, e.g.,cobaltous chloride (see, e.g., U.S. Pat. No. 4,990,284, which isincorporated herein by reference). In some embodiments, the injectionneedle can puncture a seal that permits two or more materials to comeinto contact with each other thereby providing a colorimetric change orindicator. Other embodiments include using an indicator paper layer,e.g., pH paper, which is physically separated from a layer of a slightlybasic or slightly acidic liquid, e.g., acetic acid, or baking soda andwater. Once punctured by the injection needle, the liquid contacts theindicator paper, causing the indicator paper to change color.

In some embodiments, an activatable injection event indicator in a firststate 840 a represents an intact portion of the injection needle accessregion 830 while the second state 840 b represents a ruptured portion ofthe injection needle access region 830. For example, the one or moreactivatable injection event indicators can include one or moreneedle-penetrable membranes covering at least a portion of one or moresurfaces of the wearable injection guide. The difference between thefirst state 840 a and the second state 840 b can be differentiated bythe user based on sight or based on touch.

FIGS. 9A-9C illustrate cross-sectional views of an embodiment of awearable injection guide with one or more activatable injection eventindicators that include one or more flowable dyes. FIG. 9A illustrates across-sectional view of wearable injection guide 900 prior to insertionof an injection needle, the wearable injection guide 900 comprised ofrigid material 910 and deployed on a body region 920 of an individual.Rigid material 910 includes one or more injection needle access regions930. The one or more injection needle access regions 930 include atleast one needle-penetrable reservoir 940 that contains one or moreflowable dyes 950. In some embodiments, the needle-penetrable reservoircontains one or more agents, as described herein, as well as the one ormore flowable dyes. For example, the needle-penetrable reservoir mayinclude one or more analgesic as well as one or more flowable dyes. FIG.9B is a cross-sectional view of penetration of injection needle 960through the rigid material 910 of the wearable injection guide 900 atone of the one or more injection needle access regions 930 and into theunderlying tissue of body region 920 of an individual. Injection needle960 punctures the needle-penetrable reservoir 940, releasing one or moreflowable dyes 950. FIG. 9C illustrates flow of one or more flowable dyes950 out of needle-penetrable reservoir 940 after injection needle 960has been removed from injection-needle access region 930. In someembodiments, the one or more flowable dyes flow laterally between theinner surface of the wearable injection guide and the surface of thebody region. In some embodiments, the one or more flowable dyes arecarried into the underlying tissue of the body region with insertion ofthe injection needle.

FIGS. 10A-10C illustrate cross-sectional views of an embodiment of awearable injection guide 1000 with one or more activatable injectionevent indicators that include one or more pressure sensitive materials.FIG. 10A illustrates a cross-section through wearable injection guide1000 prior to insertion of an injection needle, the wearable injectionguide 1000 composed of rigid material 1010 and deployed on a body region1020 of an individual. Rigid material 1010 includes one or moreinjection needle access regions 1030. The one or more injection needleaccess regions 1030 include an upper portion 1040 with one or morepressure sensitive materials in a first state 1050 a. FIG. 10Billustrates a cross-sectional view of wearable injection guide 1000composed of rigid material 1010 through which injection needle 1060 hasbeen inserted. As a result of inserting injection needle 1060 throughthe upper portion 1040 of the one or more injection needle accessregions 1030, the one or more pressure sensitive materials of upperportion 1040 shift to a second state 1050 b. The first state 1050 a isactivatable to the second state 1050 b by pressure exerted duringinsertion of injection needle 1060. In some embodiments, the shift fromfirst state 1050 a to second state 1050 b may be accompanied by a changein color detectable by a user of the wearable injection guide 1000. FIG.10C illustrates a cross-sectional view of wearable injection guide 1000composed of rigid material 1010 and deployed on a body region 1020 of anindividual after withdrawal of injection needle 1060. The wearableinjection guide 1000 has upper portion 1040 in a first state 1050 a,e.g., a first color, indicative of an injection needle access region1030 that has not been accessed and has upper portion 1040 in a secondstate 1050 b, e.g., a second color, indicative of an injection needleaccess region that has been accessed. It is contemplated that thepressure sensitive materials can be incorporated into any portion, e.g.,upper, middle, lower or throughout, the one or more injection needleaccess regions. In some embodiments, the one or more pressure sensitivematerials are incorporated near the one or more injection needle accessregions. For example, the one or more pressure sensitive materials canbe incorporated into at least a portion of the outer surface of therigid material that is contacted by a needle hub or syringe bodyassociated with an injection needle when the injection needle isinserted to a stop point through the rigid material at an injectionneedle access region defined by an opening.

One or more pressure sensitive materials can be incorporated into thewearable injection guide for use as an activatable injection eventindicator. In some embodiments, pressure sensitive dye chemistries canbe applied directly to the wearable injection guide or applied as a filmthat is layered into or onto the wearable injection guide. Variouscarrier plastics and/or layers, e.g., polyester can be used as carrierlayers for pressure sensitive dyes.

In some embodiments, the one or more pressure sensitive materialsinclude encapsulated single or multiple component dye systems whereinthe coating of the encapsulated dye system ruptures in response to aspecific pressure, releasing the encapsulated dye. In some embodiments,the one or more pressure sensitive materials include polymeric dyes thatundergo a conformational change in response to an exerted pressure. Insome embodiments, the one or more pressure sensitive materials include adiffusion based dye system in which a dye is induced to diffusevertically and/or horizontally, e.g., through a porous diffusion layer,in response to an exerted pressure. In some embodiments, the one or morepressure sensitive materials include hydrochromatic dyes in whichexerted pressure causes movement of an aqueous medium to come intocontact with a hydrochromatic dye layer. In some embodiments, the one ormore pressure sensitive materials include phase change compositions inwhich exerted pressure induces a chemical composition to undergo atransition from one physical state to a second physical state, e.g.,irreversible crystallization of a liquid material in response to exertedpressure with an associated color change.

Non-limiting examples of pressure sensitive materials includeencapsulated dyes and dye systems, polyacetylenes, leuco dyes, solventchemically initiated color change systems, frictionally sensitive dyes,separated dye layers, partition dyes, electron transfer dyes,two-component chemical dyes, organic and inorganic color change dyesystems, acid/base dye systems, melting waxes, sublimation dyes and thelike.

In some embodiments, the one or more pressure sensitive materialsinclude encapsulated leuco dye compositions. For example, a dye and anactivator can be separately encapsulated in microspheres and affixed toa surface of the wearable injection guide. The combination of theencapsulated dye microspheres and the activator microspheres areotherwise colorless or of a first color, but upon exposure to an exertedpressure, the capsules break, the dye and activator combine, resultingin a detectable color change. Encapsulated dyes for this purpose arecommercially available (from, e.g., NuCoat, Inc., Minneapolis, Minn.;Appleton Papers, Inc., Appleton, Wis.; Mircotek Laboratories, Inc.,Dayton, Ohio).

In some embodiments, a wearable injection guide includes a rigidneedle-penetrable material having an inner surface, and outer surface,and one or more activatable injection event indicators, the innersurface having form-fitting contours substantially conforming to atopography of a body region of an individual and the outer surfaceincluding one or more fiducials indicative of at least on treatmentparameter. The one or more activatable injection event indicators areconfigured to allow the user of the wearable injection guide todetermine where the rigid needle-penetrable material has been accessedwith an injection needle and consequently which portions of theunderlying body region have previously been injected. In someembodiments, the one or more activatable injection event indicators arepositioned on top of at least a portion of the outer surface of therigid-needle penetrable material. In some embodiments, the one or moreactivatable injection event indicators are incorporated into at least aportion of the outer surface and/or inner surface of the rigidneedle-penetrable material. In some embodiments, the one or moreactivatable injection event indicators are incorporated into at least aportion of the rigid needle-penetrable material between the outersurface of the rigid-needle penetrable material and the inner surface ofthe rigid-needle penetrable material. The one or more activatableinjection event indicators can be incorporated into at least one of acoating, a film, a layer, or an injection needle-penetrable reservoir.The one or more activatable injection event indicators can include atleast one pressure sensitive material, pressure sensitive dye, flowabledye, oxygen-sensitive dye, or moisture sensitive dye, or combinationsthereof.

FIGS. 11A-11C illustrate cross-sectional views of an embodiment of awearable injection guide 1100 with one or more activatable injectionevent indicators that include one or more pressure sensitive materials.FIG. 11A illustrates a cross-section through wearable injection guide1100 composed of needle-penetrable material 1110 and deployed on a bodyregion 1120 of an individual. The wearable injection guide 1100 furtherincludes a layer of pressure sensitive material in a first state 1130.The pressure sensitive material in a first state 1130 can be colorlessor a first color. FIG. 11B illustrates a cross-section through awearable injection guide 1100 composed of needle-penetrable material1110 through which injection needle 1150 has been inserted. As a resultof inserting injection needle 1150 through the layer of pressuresensitive material and the needle-penetrable material 1110, a portion ofthe pressure sensitive material in a first state 1130 has changed to apressure sensitive material in a second state 1140 that differs from thefirst state 1130. The pressure sensitive material in a second state 1140can be colorless, a first color or a second color. FIG. 11C illustratesa cross-sectional view of wearable injection guide 1100 composed ofrigid material 1110 and deployed on a body region 1120 of an individualafter withdrawal of injection needle 1150. The wearable injection guide1100 has a layer of pressure sensitive material in a first state 1130,e.g., a first color, indicative of an area of the wearable injectionguide 1100 that has not been accessed and has a portion of the pressuresensitive material in a second state 1140 that has changed to a secondstate that differs from the first state, e.g., a second color,indicative of where an injection needle has previously been inserted.

In some embodiments, the one or more pressure sensitive materialsinclude pressure sensing films that can be incorporated onto or into thewearable injection guide. Non-limiting examples of pressure sensingfilms include carbon papers, Fujifilm Prescale™ pressure sensing film(extreme low pressure sensitive films to super high pressure sensitivefilms; from FujiFilm, distributed by Tekscan, Boston, Mass.), and/orPressurex® films (from Sensor Products Inc., Madison, N.J.) can beutilized by way of example as film layers that can be incorporated intoa laminated layer.

Additional examples of pressure sensitive materials include, but are notlimited to those dyes disclosed in U.S. Pat. No. 5,990,199 and U.S.Patent Application 2010/0326198, which are incorporated herein byreference. Other examples include, but are not limited to, tamperevident dyes that respond to a pressure event through a color change,security inks that can be printed in a particular manner or pattern,indicator inks used in sterilization processes, tactile pressureindicating films, inks used in pressure mapping, compressible “puff”inks made with ink additives used for printing expanded patterns andprint, dye migration inks where dyes migrate only under pressure, dyetransfer inks where dyes transfer only under pressure.

In some embodiments, the activatable event indicators can be openingsdefined by the rigid material of the wearable injection guide indicatingthat injection has already been made into that site. FIGS. 12A-12Cillustrate an embodiment of a wearable injection guide that includes anactivatable event indicator that is the opening defined by the rigidmaterial left after inserting and then removing an injection needle.FIG. 12A illustrates a cross-sectional view of wearable injection guide1200 composed of rigid material 1210 and deployed on a body region 1220of an individual. The rigid material 1210 includes one or more injectionneedle access regions 1230. The one or more injection needle accessregions 1230 can further include a needle-penetrable membrane in anintact state 1240 a. FIG. 12B illustrates penetration of injectionneedle 1250 through the one or more injection needle access regions 1230and into the underlying body region 1220 of an individual. As a resultof inserting the injection needle 1250, the needle-penetrable membraneis in a punctured state 1240 b, otherwise creating an opening in therigid material 1210 of the wearable injection guide 1200. FIG. 12Cillustrates wearable injection guide 1200 comprised of rigid material1210 and deployed on surface skin area 1220 of an individual afterremoval of injection needle 1250. The wearable injection guide 1200 hasat least one needle-penetrable membrane in a first state 1240 a, e.g.,intact and indicative of an injection needle access region 1230 that hasnot been accessed and at least one needle-penetrable membrane in asecond state 1240 b, e.g., punctured and indicative of an injectionneedled access region 1230 that has been accessed. In some embodiments,the user can visually see if the needle-penetrable membrane is intact orpunctured. In some embodiments, the user can feel if theneedle-penetrable membrane is intact or punctured. In this way, the usercan determine which injection needle access regions have been accessedand which have not been accessed.

FIG. 13 illustrates a method for administering a treatment to anindividual implemented with a wearable injection guide, the wearableinjection guide constructed of a rigid material formed to substantiallyconform in shape to a topography of a body region of an individual andincluding one or more injection needle access regions arranged in atreatment pattern. The method includes deploying the wearable injectionguide onto the body region of the individual, wherein the body regioncan include at least a portion of a face, torso, abdomen, head, neck,upper extremity, lower extremity, or buttocks region of an individual.In some embodiments, the wearable injection guide is deployed on all orpart of a head or neck region, e.g., face, scalp, nose, forehead, or earregions. Block 1300 shows inserting one or more injection needlesthrough the one or more injection needle access regions of the wearableinjection guide. Block 1310 depicts injecting at least one injectableagent through the one or more injection needles into an underlyingtissue of the body region of the individual.

FIG. 14 illustrates aspects of the method depicted in FIG. 13. FIG. 14illustrates that in some embodiments, block 1300 can include one or moreof optional blocks 1400 and 1410. In some embodiments, inserting the oneor more injection needles through the one or more injection needleaccess regions of the wearable injection guide can include inserting theone or more injection needles at a 90 degree angle relative to theunderlying tissue of the body region of the individual, as illustratedin block 1400. In some embodiments, inserting the one or more injectionneedles through the one or more injection needle access regions of thewearable injection guide includes inserting the one or more injectionneedles through the one or more injection needle access regions at lessthan a 90 degree angle relative to the underlying tissue of the bodyregion of the individual, as illustrated in block 1410. The angle atwhich the one or more injection needles are inserted through the one ormore injection needle access regions of the wearable injection guide isdependent upon the nature of the injectable agent and the location ofthe underlying tissue of the body region of the individual into whichthe injectable agent is being injected. For example, injections into themuscle with, e.g., penicillin may be done with an injection needlethrough the wearable injection guide at a 90 degree angle; injectionsinto the subcutaneous tissue with, e.g., morphine, may be done with aninjection needle through the wearable injection guide at a 45 degreeangle; and injections into the epidermis or dermis with, e.g., a vaccinemay be done with an injection needle through the wearable injectionguide at a 10 to 15 degree angle.

In an embodiment, the angle at which the one or more injection needlesare inserted through the one or more injection needle access regions ofthe wearable injection guide is dependent upon the angle of the one ormore injection needle access regions transecting the wearable injectionguide, e.g., one or more areas of rigid material of the wearableinjection guide defining one or more openings, that have beenmanufactured into the wearable injection guide.

FIG. 15 shows further aspects of the method illustrated in FIG. 13 foradministering an injection treatment to an individual with a wearableinjection guide. FIG. 15 illustrates that in some embodiments, themethod can include block 1500. Block 1500 depicts aligning one or morealignment marks on the wearable injection guide with one or morereference points on the body region of the individual. Block 1500 caninclude one or more optional blocks 1510 and 1520. Block 1510illustrates aligning one or more alignment marks on the wearableinjection guide with one or more reference marks placed on a surface ofthe body region of the individual by a physician, other practitioner, orthe individual themselves. For example, a physician, other practitioner,or the user, in the case of self-injection, can place reference marks inink on the surface of the body region of the individual for use inaligning with one or more alignment marks on the wearable injectionguide. Block 1520 illustrates aligning one or more alignment marks onthe wearable injection guide with one or more topographical landmarks ofthe body region. Block 1520 further includes optional block 1530 whichillustrates aligning the one or more alignment marks on the wearableinjection guide with one or more of a pigmentation, a pigmented area, askin texture pattern, a tattoo, a subsurface blood vessel, an anatomicalfeature, an eye, nose, or lips. Non-limiting examples of a pigmentedarea include freckles, moles, birth marks, or other pigmented areas onthe surface of an individual's skin. Non-limiting examples of anatomicalfeatures include eyes, nose, lips, cheek bones, a joint, a belly button,or any other anatomical feature that can be used to align a wearableinjection guide onto a body region of an individual. For example, awearable injection guide for use on an individual's face may conform inshape to a topography of the individual's face including the nose andeye regions and as such fit snuggly into place. An extensive list oftopographical landmarks of the facial area are described in Buckley etal., Am. J. Psychiatry (2005) 162:606-608, which is incorporated hereinby reference.

FIG. 16 shows further aspects of the method illustrated in FIG. 13 foradministering an injection treatment to an individual with a wearableinjection guide. FIG. 16 illustrates that in some embodiments, themethod can include block 1600. Block 1600 depicts immobilizing thewearable injection guide on the body region of the individual. In someembodiments, the wearable injection guide is immobilized on to the bodyregion of the individual for only a short period of time, e.g., duringan office visit to a physician or other practitioner. In someembodiments, the wearable injection guide is immobilized on the bodyregion of the individual for a prolonged period of time, e.g., days orweeks, to accommodate a full course of injection treatment. Block 1600can include one or more optional blocks 1610 and 1620. Block 1610depicts immobilizing the wearable injection guide by adhering thewearable injection guide on the body region of the individual with areversible adhesive. For example, the wearable injection guide can beadhered on the body region of the individual with one or more strips ofmedical rated double stick tape. As another example, the wearableinjection guide can be adhered on the body region of the individual witha coating of adhesive, e.g., URO-Bond® IV Silicone Skin Adhesive (from,UROCARE Products, Pomona, Calif.). In some embodiments, the wearableinjection guide is immobilized by using a lotion or gel, e.g., petroleumjelly, to coat the inner surface of the wearable injection guide andcreate friction with the underlying skin of the individual. Block 1620depicts immobilizing the wearable injection guide by strapping thewearable injection guide on the body region of the individual with oneor more body portion-encircling pieces. For example, the wearableinjection guide can be strapped on the body region of the individualusing a series of nylon straps including compatible portions of anadjustable loop and hook system, e.g., Velcro®. In some embodiments, thebody portion-encircling pieces can include a sleeve or a clamp. Forexample, a snug-fitting sleeve can be used to immobilize the wearableinjection guide on an upper or lower extremity. In some embodiments, thewearable injection guide is incorporated into a piece of clothing, e.g.,a tee-shirt or shorts.

FIG. 17 shows further aspects of the method illustrated in FIG. 13 foradministering an injection treatment to an individual with a wearableinjection guide. FIG. 17 illustrates that in some embodiments, block1310 can include one or more of optional blocks 1700 and 1710. Block1700 depicts optionally injecting the at least one injectable agentthrough the one or more injection needles into one or more of epidermis,papillary dermis, reticular dermis, subcutis, or muscle of theunderlying tissue of the body region of the individual. For example, themethod can include using the wearable injection guide to inject one ormore doses of botulinum neurotoxin into the papillary dermis of anindividual's face. For example, the method can include using thewearable injection guide to inject one or more doses of fertilityhormones into the muscle of an individual's upper thigh. In someembodiments, the method can include injecting the at least oneinjectable agent into one or more lines, wrinkles or folds on anindividual's face, e.g., as part of a cosmetic treatment. Block 1710depicts optionally injecting the at least one injectable agent into theunderlying tissue of one or more of a forehead, a glabella, aperiorbital region, a preauricular region, an ear, a cheek, a lip, anasolabial fold, a labial region, a perilablial region, a sublabialregion, a labiomental crease, or a neck region of the individual. Forexample, the method can include using the wearable injection guide toinject one or more doses of collagen into one or more of the nasolabialfolds of an individual's face.

FIG. 18 shows further aspects of the method illustrated in FIG. 13 foradministering an injection treatment to an individual with a wearableinjection guide. FIG. 18 illustrates that in some embodiments, block1310 can include one or more of optional blocks 1800, 1810, 1820, 1830,1840, and 1850. Block 1800 depicts optionally injecting at least oneneurotoxin. In some embodiments, the at least one neurotoxin can includeone or more forms of the neuromuscular blocking agent botulinum toxin.In some embodiments, at least one botulinum toxin is used for treatingwrinkles in a facial region of an individual. For example, the wearableinjection guide can be used to guide injection of at least one botulinumtoxin into wrinkles associated with the forehead, e.g., glabellar frownlines, of an individual's face. In some embodiments, at least onebotulinum toxin is used in conjunction with the wearable injection guideto treat one or more of primary axillary hyperhidrosis (excessivesweating), blepharospasm (eye twitching), strabismus (cross-eyed),cervical dystonia, chronic migraine, and upper limb spasticity.Non-limiting examples of botulinum toxin for use as an injectable agentinclude onabotulinumtoxinA, abotulinumtoxinA, incobotulinymtoxinA,rimabotulinumtoxinB and like agents (see, e.g., Park et al., Clin.Ophthalmol. (2011) 5:725-732, which is incorporated herein byreference).

Block 1810 of FIG. 18 depicts optionally injecting at least one of asubcutaneous volume enhancer or dermal filler. Block 1810 furtherincludes optional blocks 1820, 1830, and 1840. Block 1820 illustratesoptionally injecting at least one collagen filler into an underlyingtissue of the body region of the individual. For example, the wearableinjection guide can be used to guide injection of at least one collagenfiller into the upper or lower lip of an individual to achieve lipaugmentation. Other non-limiting examples of injecting collagen fillerinclude injecting into the grooves and/or lines that form wrinkles andsagging skin of the face. In some embodiments, the at least one collagenfiller can be used to treat depressed scars, e.g., pitted acne scars.Non-limiting examples of bovine-, porcine-, or human-derived collagenfillers include Artefill, Cosmoplast/Cosmoderm, Evolence, andZyderm/Zyplast. For example, Zyplast can be injected using a 30-gaugeneedle into the middle and deep reticular dermis to correct deeper linesand wrinkles or for lip augmentation. In some embodiments, the collagenfiller can be combined with one or more other agents such as, forexample, botulinum toxin or an analgesic. A non-limiting example of acollagen filler combined with another agent includes Zyderm whichincludes lidocaine as an analgesic. Collagen fillers can be used forwrinkles, fine lines, deep folds, and lip augmentation. The depth ofinjection can vary from superficial/papillary dermis for treatment ofwrinkles and fine lines to mid to deep dermis for treatment of moderateto deep facial wrinkles and folds (see, e.g., Hanke et al., J. Am. Acad.Dermatol. (2011) 64:S66-85, which is incorporated herein by reference).

Block 1830 of FIG. 18 depicts optionally injecting at least onehyaluronic acid filler into an underlying tissue of the body region ofthe individual. For example, injecting at least one hyaluronic acidfiller can be used to temporarily smooth wrinkles, augment lips, reducefacial folds, and attenuate scars. Non-limiting examples of hyaluronicfillers include Belotero Balance (from Merz Aesthetics); Hyalaform,Juvederm Ultra and Juvederm Ultra Plus (from Allergan, Inc.); Perlaneand Restylane (from Medicis Aesthetics Inc.) PREVELLE and Puragen (fromMentor Corp.). Hyaluronic acid can be injected with needles ranging insize from 27 to 30 gauge to a depth ranging from the mid to deep dermisto the superficial subcutaneous space (see, e.g., Allemann & BaumannClinical Interventions in Aging (2008) 3:629-634; Brant & CazzanigaClinical Interventions in Aging (2008) 3:153-159, which are incorporatedherein by reference).

Block 1840 of FIG. 18 depicts optionally injecting at least one ofadipose, fibroblasts, calcium microspheres, or poly L lactic acid intoan underlying tissue of the body region of the individual. In someembodiments, adipose tissue can be isolated from one region of theindividual's body, e.g., the abdomen or thigh, and reinjected intoanother region of the individual's body, e.g., the face, to augment orrepair features of the facial region (see, e.g., Meier et al., Arch.Facial Plast. Surg. (2009) 11:24-28, which is incorporated herein byreference). In some embodiments, fibroblasts can be isolated from theindividual, expanded in vitro, and reinjected into the individual (see,e.g., U.S. Pat. No. 7,846,465, which is incorporated herein byreference). In some embodiments, calcium hydroxyapatite microspheres(e.g., Radiesse®; BioForm Medical, Inc., San Mateao, Calif.) can beinjected using a 27 gauge needle, e.g., to correct moderate to severenasolabial folds. The calcium hydroxyapatite microspheres can beinjected with an aqueous gel, the latter of which is highly viscous,requiring a larger bore needle, e.g., a 27 gauge needle. The geldegrades over the course of several months, leaving behind the calciummicrospheres to stimulate collagen synthesis. In some embodiments, polyL lactic acid (PLLA, e.g., Sculptra®; Dermik Laboratories, Bridgewater,N.J.) can be injected at or below the level of the dermal-subcutaneousjunction for augmentation of the lower two-thirds of the face inindividuals with lipoatrophy associated with HIV infection. PLLA canalso be used for cosmetic purposes as a deep dermal filler (see, e.g.,Sherman Clin. Dermatol. (2009) 27:S23-S32, which is incorporated hereinby reference). PLLA is viscous solution and as such requires injectionusing larger bore needles, e.g., 25- or 26-gauge needles. In someembodiments, PLLA may be used in conjunction with lidocaine and/orepinephrine to lessen the pain of injection with a relatively largeneedle. For example, lidocaine and/or epinephrine can be included in theinjection needle along with the PLLA. In some embodiments, lidocaineand/or epinephrine may be included as part of the wearable injectionguide, e.g., as a coating on the inner surface of the wearable injectionguide.

Block 1850 of FIG. 18 depicts optionally injecting at least one ofinsulin, an antibiotic, a hormone, a chemotherapeutic, or a biologicalagent into an underlying tissue of the body region of the individual. Insome embodiments, injecting at least one of insulin includes injectingat least one of a rapid acting insulin, short-acting insulins,intermediate-acting insulins, premixed insulins, or long-actinginsulins. Commercial sources of insulin are available from, e.g., EliLilly (Indianapolis, Ind.), Sanofi-Aventis (Bridgewater N.J.), NovoNordisk Inc. (Princeton, N.J.), or Pfizer (New York, N.Y.). In someembodiments, injecting at least one antibiotic includes injecting atleast one of penicillins, e.g., penicillin, ampicillin, piperacillin;cephalosporins and other beta-lactam drugs, e.g., cefazolin, ertapenem;tetracyclines, e.g., doxycycline; macrolides, e.g., erythromycin;clindamycin; aminoglycosides, e.g., streptomycin, gentamicin;spectinomycin; sulfonamides; quinolones and fluoroquinolones. In someembodiments, injecting at least one hormone includes injecting at leastone of a hypothalamic or pituitary hormone, synthetic analogs, and/orantagonist thereof, e.g., adrenocorticotropic hormone,corticotropin-releasing hormone, follicle stimulating hormone,gonadotropin-releasing hormone and synthetic analogs, luteinizinghormone, prolactin; at least one of an adrenocoricosteroid, syntheticanalogs, and/or antagonists thereof, e.g., dexamethasone,hydrocortisone, prednisolone, methylprednisolone, triamicinolone;gonadal hormones, e.g., estrogens, progestins, androgens, and anabolicsteroids; glucagon and analogs thereof. In some embodiments, injectingat least one cancer chemotherapeutic or associated therapy includesinjecting at least one of alpha interferon, erythropoietin andderivatives thereof, colony stimulating factor and analogs thereof,somatostatin and analogs thereof. In some embodiments, injecting atleast one biological agent includes injecting at least one ofteriparatide, etanercept, interferon, abatacept, anakinra, bevacizumab,cetuximab, cyclophosphamide, gemtuzumab, muromonab-CD3, omalizumab,pegademase, immune globulin, tacrolimus, or tositumomab.

In some embodiments, injecting the at least one injectable agent throughthe one or more injection needles into an underlying tissue of the bodyregion of an individual includes injecting at least one injectable agentin combination with one or more analgesic agents, for example lidocaine,to lessen the pain associated with injection.

Block 1860 of FIG. 18 depicts further aspects of the method of FIG. 13for administering an injection treatment to an individual with awearable injection guide. block 1860 illustrates optionally using thewearable injection guide with at least one injectable agent to treat oneor more conditions including one or more of a cosmetic disorder, acosmetic need, a pain disorder, a blood vessel disorder, a microbialinjection, an inflammatory disorder, an endocrine disorder, aneurological disorder, a muscle disorder, a skin disorder, a fertilitydisorder, cancer, or a vitamin deficiency.

FIG. 19 shows further aspects of the method illustrated in FIG. 13 foradministering an injection treatment to an individual with a wearableinjection guide. FIG. 19 illustrates that in some embodiments, themethod can include block 1900. Block 1900 depicts altering thetemperature of the wearable injection guide to a temperature above orbelow about 98.6° F. (or above or below about 37° C.).

In some embodiments, the wearable injection guide is cooled below about98.6° F. (37° C.) prior, during and/or after injection with aninjectable agent. Cooling the body region may lessen the pain associatedwith injecting the one or more injection needles and/or prevent swellingand/or bruising post injection. In some embodiments, the wearableinjection guide is cooled by placing the wearable injection guide in acooling device prior to placement onto a body region of an individual.For example, the wearable injection guide can be stored in a coolingdevice until use. Alternatively, the wearable injection guide can beplaced into the cooling device just prior to use for a sufficient timeto cool the wearable injection guide to an appropriate temperature. Thecooling temperature can range from about 10° C. to about 0° C. It isunderstood that the cooling temperature can fall outside this range, butis contemplated to be sufficiently cool enough to reduce pain andswelling but not so cold as to be painful to the underlying tissue ofthe body region. Non-limiting examples of cooling devices for thispurpose include a refrigerator, a freezer, or an ice bath. In someembodiments, cooling the wearable injection guide can include using acooling mechanism associated with the wearable injection guide, e.g., achemical or thermoelectric cooling mechanism as discussed above herein.

In some embodiments, the wearable injection guide is heated above about98.6° F. (37° C.) prior, during and/or after injection with aninjectable agent. Heating the body region covered by the wearableinjection guide may increase vasodilation and/or circulation in theunderlying tissue. In some embodiments, the wearable injection guide isheated by placing the wearable injection guide in a heating device priorto placement onto a body region of an individual. For example, thewearable injection guide can be stored in a heating device until use.Alternatively, the wearable injection guide can be placed into theheating device just prior to use for a sufficient time to heat thewearable injection guide to an appropriate temperature. The heatingtemperature can range from about 40° C. to about 45° C. It is understoodthat the heating temperature can fall outside this range, but iscontemplated to be sufficiently hot enough to increase circulation butnot so hot as to be painful or damaging to the underlying tissue of thebody region. Non-limiting examples of heating devices for this purposeinclude a warming oven, a microwave, or hot water bath. In someembodiments, heating the wearable injection guide can include using aheating mechanism associated with the wearable injection guide, e.g., achemical or thermoelectric heating mechanism as discussed above herein.

FIG. 20 illustrates a method of administering an injection treatment toan individual with a wearable injection guide, the wearable injectionguide including a rigid needle-penetrable material with an inner surfaceand an outer surface, the inner surface having a form fitting contoursubstantially conforming to the topography of the body region of theindividual and the outer surface having one or more fiducials indicativeof at least one treatment parameter. Block 2000 shows aligning one ormore alignment marks of a wearable injection guide with one or morereference points on a body region of an individual. Block 2010 depictsimmobilizing the wearable injection guide on the body region of theindividual. Block 2020 depicts inserting one or more injection needlesthrough the rigid needle-penetrable material of the wearable injectionguide at or near the one or more fiducials. Block 2030 depicts injectingat least one injectable agent from the one or more injection needlesinto an underlying tissue of the body region of the individual.

FIG. 21 illustrates further aspects of the method of FIG. 20. FIG. 21illustrates that in some embodiments, the method of FIG. 20 can includethe optional step of block 2100. Block 2100 depicts deploying thewearable injection guide onto the body region of the individual. Block2100 further includes the optional steps of deploying the wearableinjection guide onto the body region of a face of the individual asillustrated in block 2110; onto the body region of a torso of theindividual as illustrated in block 2120; onto the body region of anabdomen of the individual as illustrated in block 2130; onto the bodyregion of a head of an individual as illustrated in block 2140; onto thebody region of a neck of the individual as illustrated in block 2150;onto the body region of an upper extremity area of the individual asillustrated in block 2160; onto the body region of a lower extremityarea of the individual as illustrated in block 2170; or onto the bodyregion of a buttocks area of the individual as illustrated in block2180. The deployment of the wearable injection guide on a specific bodyregion of the individual is dependent upon the condition being treatedand the treatment regimen. For example, specific treatment of theindividual's face or the individual's neck would necessarily include awearable injection guide specifically designed for use on a face orneck, respectively. In another example, a self-injection treatmentregimen that includes intramuscular injections, e.g., antibiotic orfertility treatment, may include a wearable injection guide designed foruse on any of a number of body regions easily accessible to theindividual, e.g., the thigh or abdomen areas.

FIG. 22 illustrates further aspects of the method of FIG. 20. In someembodiments, aligning one or more alignment marks of a wearableinjection guide with one or more reference points on a body region of anindividual can include aligning the one or more alignment marks with oneor more reference marks placed on the body region of the individual bythe individual, a physician, or other person with, for example, awashable ink. In some embodiments, the one or more reference pointsrepresent permanent features of the body region. Block 2000 furtherincludes optional block 2200. Block 2200 depicts optionally aligning theone or more alignment marks of the wearable injection guide with one ormore topographical landmarks on the body region of the individual. Block2200 can optionally include block 2210. Block 2210 depicts optionallyaligning the one or more alignment marks of the wearable injection guidewith one or more pigmentation, pigmented area, skin texture pattern,tattoo, blemish, scar, anatomical feature, or subsurface blood vessel ofat least at portion of the body region of the individual. Two andpreferably three or more reference points are used to align the wearableinjection guide onto the body region of the individual.

Returning to FIG. 20, in some embodiments, the method for administeringan injection treatment to an individual with a wearable injection guideincluding immobilizing the wearable injection guide on the body regionof the individual, as illustrated in block 2010, can include adheringthe wearable injection guide on the body region of the individual with areversible adhesive. In some embodiments, the reversible adhesive isincluded on the inner surface of the wearable injection guide. In someembodiments, the reversible adhesive is applied to the inner surface ofthe wearable injection guide and/or the body region of the individualjust prior to deploying the wearable injection guide. In someembodiments, immobilizing the wearable injection guide on the bodyregion of the individual, as illustrated in block 2010, can includeimmobilizing the wearable injection guide on the body region of theindividual with one or more body portion-encircling pieces.

Returning to FIG. 20, in some embodiments, the method for administeringan injection treatment to an individual with a wearable injection guideincluding inserting one or more injection needles through the rigidneedle-penetrable material of the wearable injection guide at or nearthe one or more fiducials, as illustrated in block 2020, can includeinserting the one or more injection needles at a 90 degree anglerelative to the outer surface of the wearable injection guide. In someembodiments, injecting the one or more needles containing at least oneinjectable agent through the rigid needle-penetrable material of thewearable injection guide at or near the one or more fiducials, asillustrated in block 2020, can include inserting the one or moreinjection needles at less than a 90 degree angle relative to the outersurface of the wearable injection guide. In some embodiments, allinsertions of the one or more injection needles through the wearableinjection guide are done at either 90 degrees or less than 90 degrees.In some embodiments, the insertions of the one or more injection needlesthrough the wearable injection guide can vary from 90 degrees or less.The angle of the needle insertion will be dependent upon the injectableagent, the needle depth, and the portion of the body region beinginjected. For example, intramuscular injection with penicillin, e.g.,may be injected at 90 degree, i.e., straight through the wearableinjection guide. In contrast, subcutaneous injections with collagenfiller, e.g., may be injected at less than 90 degrees, i.e., at an anglerelative to the outer surface of the wearable injection guide.

FIG. 23 illustrates further aspects of the method of FIG. 20. FIG. 23illustrates that in some embodiments, the method of FIG. 20 canoptionally include block 2300. Block 2300 depicts optionally insertingthe one or more injection needles through the needle-penetrable materialof the wearable injection guide to a stop point. Block 2300 canoptionally include blocks 2310, 2320, 2330, or 2340. Block 2310 depictsoptionally inserting the one or more injection needles through the rigidneedle-penetrable material of the wearable injection guide to a stoppoint defined by the outer surface of the wearable injection guide. Forexample, the outer surface may be separated from the inner surface ofthe wearable injection guide by a thickness of rigid needle-penetrablematerial that limits how far an injection needle of a given length canbe inserted through the wearable injection guide and into the underlyingtissue of the body region. Block 2320 depicts optionally inserting theone or more injection needles through the rigid needle-penetrablematerial of the wearable injection guide to a stop point defined by alength of the one or more injection needles. For example, standardinjection needles can range in length from 3/16 inches (5 mm) to 1½inches (38 mm) from the tip of the needle bevel to the needle hub. Thechoice of injection needle will also be dependent upon how deep theinjection is intended to go. For example, needles ranging in length from½ inch to ⅝ inch can be used for subcutaneous injections while needlesranging in length from 1 inch to 1½ inch can be used for intramuscularinjections. Furthermore, the needle length may also be considered in thecontext of the desired needle depth required and the thickness of thewearable injection guide. Block 2330 depicts optionally inserting theone or more injection needles through the rigid needle-penetrablematerial of the wearable injection guide to a stop point defined by astructural feature of the one or more injection needles. For example,the stop point may be defined by a structural feature of the one or moreinjection needles, e.g., the needle hub or the attached syringe. Therigid needle-penetrable material of the wearable injection guide mayallow for penetration of a sharp injection needle, but inhibits furtherinsertion of the injection needle once the needle hub or attachedsyringe reaches the outer surface of the wearable injection guide. Block2340 depicts optionally inserting the one or more injection needlesthrough the rigid needle-penetrable material of the wearable injectionguide to a stop point defined by a preferred depth of injection into theunderlying tissue of the body region of the individual. For example, aphysician, other practitioner, or the individual may have knowledge asto how deep an injection needle should be injected based on the type ofinjectable agent being injected and the location of the injection. Insome embodiments, the one or more fiducials on the outer surface of thewearable injection guide may provide guidance as to the injection depthand/or length of needle for use at any given injection site.

FIG. 24 illustrates further aspects of the method of FIG. 20. FIG. 24illustrates that in some embodiments, the method of FIG. 20 includinginjecting at least one injectable agent through the one or moreinjection needles into the underlying tissue of the body region of theindividual optionally includes blocks 2400, 2410, 2420, 2430, or 2440.Block 2400 depicts optionally injecting the at least one injectableagent into epidermis. Block 2410 depicts optionally injecting the atleast one injectable agent into papillary dermis. Block 2420 depictsoptionally injecting the at least one injectable agent into reticulardermis. Block 2430 depicts optionally injecting the at least oneinjectable agent into subcutis. Block 2440 depicts optionally injectingthe at least one injectable agent into muscle. Block 2030 optionallyincludes block 2450. Block 2450 depicts optionally injecting the atleast one injectable agent into a forehead, a glabella, a periorbitalregion, an auricular region, an ear, a cheek, a lip, a nasolabial fold,a labial region, a perilabial region, a sublabial region, a labiomentalcrease, or a neck region of the individual. The depth to which a needleis injected is dependent on the condition being treated and theinjectable agent being injected, as discussed above herein.

FIG. 25 illustrates further aspects of the method of FIG. 20. FIG. 25illustrates that in some embodiments, the method of FIG. 20 includinginjecting the at least one injectable agent from the one or moreinjection needles into the underlying tissue of the body region of theindividual optionally includes blocks 2500, 2510, 2520, 2530, or 2540.Block 2500 depicts optionally injecting at least one neurotoxin,non-limiting examples of which have been described above herein. Block2510 depicts optionally injecting at least one of a subcutaneous volumeenhancer or dermal filler. Block 2510 further optionally includes blocks2520, 2530, and 2540. Block 2520 depicts optionally injection at leastone of a collagen filler, non-limiting examples of which have beendescribed above herein. Block 2530 depicts optionally injecting at leastone of a hyaluronic acid filler, non-limiting examples of which havebeen described above herein. Block 2540 depicts optionally injecting atleast one of adipose, fibroblasts, calcium microspheres, or poly Llactic acid, non-limiting examples of which have been described aboveherein. Block 2030 further optionally includes block 2550 which depictsoptionally injecting at least one of insulin, antibiotic, hormone,chemotherapeutic, or biological agent, non-limiting examples of whichhave been described above herein.

FIG. 26 illustrates further aspects of the method of FIG. 20. FIG. 26illustrates that in some embodiments, the method of FIG. 20 foradministering an injection treatment to an individual with a wearableinjection guide can optionally include blocks 2600 and/or 2610. Block2600 depicts optionally altering the temperature of the wearableinjection guide to a temperature above or below about 98.6° F. Coolingthe wearable injection guide before and/or during the injectiontreatment and consequently cooling the body region upon which thewearable injection guide is deployed can reduce the pain of injectionand/or reduce swelling or bruising associated with injection. Heatingthe wearable injection guide before and/or during the injectiontreatment and consequently heating the body region upon with thewearable injection guide is deployed can increase vascular dilation andblood circulation. In some embodiments, the wearable injection guide isheated or cooled by placing the guide into a heating or cooling device,respectively, prior to deployment on the individual. In someembodiments, the wearable injection guide has a thermal-regulatingmechanism that allows it to heat or cool, e.g., a chemical orthermoelectric mechanism as discussed above herein.

Block 2610 of FIG. 26 depicts optionally verifying with one or morepatient identifiers that the wearable injection guide is appropriate foruse with the individual. In some embodiments, the one or more patientidentifiers can include a bar code or RFID tag that is specific to theindividual and is read prior to or after deployment of the wearableinjection guide onto the body region of the individual. In someembodiments, the one or more patient identifiers can include one or morereference points on the body region of the individual. The ability toalign one or more alignment marks on the wearable injection guide withone or more reference points on the body region of the individual, e.g.,a unique pattern of topographical landmarks, can be used to determine ifthe wearable injection guide is appropriate for use for the individual.In some embodiments, other forms of patient identifiers can be used,non-limiting examples of which include vein pattern recognition, facialrecognition, iris recognition, or voice recognition. In someembodiments, verifying with one or more patient identifiers that thewearable injection guide is appropriate for use on the individual can bedone using one or more skin measurements, e.g., skin thickness, melaninmeasurement, skin surface pH, skin roughness, skin conductance, sweatducts, sebum secretions, and the like (see, e.g., Wa & Maibach Skin Res.Technol. (2010) 16:38-54, U.S. Patent Application 2008/0166029, whichare incorporated herein by reference). In some embodiments, the one ormore patient identifiers can be assessed using one or more sensorsincorporated into the wearable injection guide. Some examples ofbiometric sensor, for example, are described in U.S. Patent Application2008/0262376, which is incorporated herein by reference.

The method of FIG. 20 further includes using the wearable injectionguide with at least one injectable agent to treat one or moreconditions, non-limiting examples of which include one or more of acosmetic disorder, a cosmetic need, a pain disorder, a blood vesseldisorder, a microbial infection, an inflammatory disorder, an endocrinedisorder, a neurological disorder, a muscle disorder, a skin disorder, afertility disorder, cancer, or a vitamin deficiency.

FIG. 27 illustrates a method of generating a wearable injection guidefor an individual. Block 2700 shows acquiring one or more digital imagesof a body region of the individual. As defined herein, digital imagesincludes any digital information related to the body region and theunderlying tissue. In some embodiments, acquiring one or more digitalimages of the body region of an individual includes acquiring one ormore images of the surface topography of the body region. In someembodiments, one or more contact scanners can be used to acquire one ormore digital images of the body region of an individual by running aprobe over the surface of the body region. In some embodiments, one ormore non-contact scanners can be used to acquire one or more digitalimages of the body region of an individual by measuring reflected ordeflected radiation or light from the body region. In some embodiments,the one or more digital images of a body region of the individual can beacquired using one or more of an image capture system, e.g., a digitalcamera. In some embodiments, the one or more images can be capturedusing one or more of a laser scanner in combination with one or morecharge-coupled device. Block 2710 depicts creating a digitally renderedmodel of the wearable injection guide from the one or more digitalimages of the body region of the individual. For example, surfacescanning software can be used to import individual points of the bodyregion, e.g., of the face, and then combine them in the X, Y, and Z axesto render a three-dimensional representation of the topography of thebody region. The three-dimensional representation of the topography ofthe body region can be combined with information regarding the finalthickness of the wearable injection guide, e.g., uniform or variable, tocreate the digitally rendered model of the wearable injection guide. Anyof a number of modeling programs can be used for this purpose, as willbe described below. Block 2720 illustrates adding one or more digitallyrendered fiducials indicative of a treatment parameter to the digitallyrendered model of the wearable injection guide. The one or moredigitally rendered fiducials can include one or more colors, letters,shapes, numbers, crosshairs, or combinations thereof. Block 2730illustrates forming the wearable injection guide from the digitallyrendered model of the wearable injection guide, the formed wearableinjection guide including one or more fiducials indicative of the atleast one treatment parameter, the one or more fiducials correspondingto the one or more digitally rendered fiducials on the digitallyrendered model of the wearable injection guide. For example, forming thewearable injection guide can include using a three-dimensional printingtechnology. The at least one treatment parameter can include one or moreinjectable agents to be injected at said one or more fiducials, one ormore dosages of one or more injectable agents to be injected at said oneor more fiducials, and the depth of the needle injection for injectingone or more injectable agents at said one or more fiducials.

FIG. 28 shows further aspects of the method of FIG. 27. FIG. 28 showsoptional steps in blocks 2800, 2810, and 2820 for acquiring one or moredigital images of the body region of the individual. Block 2800 depictsoptionally acquiring one or more digital images of the topography of thebody region of the individual. The topography of the body region caninclude both the micro-topography, e.g., the texture and/or pattern ofthe skin surface, and the macro-topography, e.g., anatomical featuressuch as nose, lips, cheeks, large wrinkle, joints, and the like.

Block 2810 depicts optionally acquiring one or more digital images ofone or more topographical landmarks associated with the body region ofthe individual. Block 2820 further depicts optionally acquiring one ormore digital images of one or more pigmentation, pigmented areas,tattoos, skin texture pattern, blemishes, scars, anatomical features, orsubsurface blood vessels associated with the body region.

In some embodiments, the one or more digital images of one or moretopographical landmarks associated with the body region of theindividual can include one or more reference points for aligning thewearable injection guide to the body region of the individual. The oneor more reference points observed in the one or more digital images canbe used to determine where alignment marks should be added to thedigitally rendered model of the wearable injection guide prior tomanufacture.

In some embodiments, the one or more digital images of one or moretopographical landmarks associated with the body region of theindividual can include features of the body region that are themselvesthe focus of treatment, for example a scar (e.g., an acne scar) or otherblemish on the surface of the skin. For example, one or more digitalimages of a scar on the body region can aide in determining where theone or more digitally rendered fiducials indicative of a treatmentparameter should be added to the digitally rendered model of thewearable injection guide. As an example, injectable dermal fillers canbe used to raise depressions in the surface of the skin caused by severeacne scarring.

In some embodiments, the one or more digital images of one or moretopographical landmarks associated with the body region of theindividual can include features contraindicated as sites of injection.For example, injecting a neurotoxin, e.g., botulinum toxin, or otherinjectable agents directly into a blood vessel may lead to unwantedsystemic complications. As such, a treatment regimen that includesbotulinum toxin injection, for example, would necessarily avoidoverlaying the one or more fiducials on the wearable injection guidewith one or more blood vessels associated with the body region of theindividual. In an embodiment, one or more of the superficial bloodvessels on the body region of the individual can be imaged andincorporated into the digitally rendered model of the wearable injectionguide. Non-limiting examples of non-invasive imaging techniques forsuperficial blood vessels include photoacoustic imaging, ultrasound,near-infrared imaging (see, e.g., Wiering a et al., Ann Biomed Eng(2006) 34:1870-1878, which is incorporated herein by reference). Imagesof superficial blood vessels generated using one or more of thesemethods can be combined with the images of the topography of the bodyregion of the individual to aid in adding the one or more digitallyrendered fiducials to the digitally rendered model of the wearableinjection guide.

FIG. 29 shows further aspects of the method illustrated in FIG. 27 forgenerating a wearable injection guide. FIG. 29 illustrates that in someembodiments, block 2700 can optionally include block 2900. Block 2900depicts optionally acquiring the one or more images with one or moredigital cameras. For example, one or more digital cameras can be set upto acquire one or more images of the body region of the individual fromvarious angles and/or directions in a process known asstereophotogrammetry. In some embodiments, the one or more digitalimages can include one or more camera images with sufficient contrast todifferentiate between the color of the skin and other skin features,e.g., freckles, tattoo, moles, or blemishes.

Block 2910 of FIG. 29 depicts options acquiring the one or more digitalimages with at least one of an active scanner or a passive scanner. Theat least one active or passive scanner can acquire one or more scans ofthe individual. The at least one active or passive scanner can acquireone or more scans of the individual from one or more directions. Forexample, multiple scans taken from multiple directions will allow forobtaining information from all sides of the individual.

In some embodiments, the one or more digital images are acquired with atleast one active scanner. An active scanner emits some form of radiationor light which when beamed on an individual creates a measureablereflection. The emitted radiation or light can include electromagneticradiation, ultrasound or x-ray. Non-limiting examples of activenon-contact scanners include hand-held laser scanners as well as anumber of three-dimensional scanners (3D scanners) includingtime-of-flight scanners, triangulation laser scanners, structured-lightscanners, and modulated light scanners (see, e.g., Kolbe et al.,Computer Graphics Forum (2010) 29:141-159, which is incorporated hereinby reference). In some embodiments, the one or more active scanners caninclude one or more triangulation scanners in which a laser emitter, alaser dot on the surface being scanned, and a detection camera are usedto triangulate the distance between the laser and the laser dot. Forexample, the body region of the individual can be scanned at a setdistance (e.g., 1-10 mm) as controlled by a tape measure fixed to thecamera. The topography of the body region, e.g., the face,differentially reflects the distorted light of the laser, which is thencaptured by a charge-coupled device (CCD) associated with the camera andconverted into distance information using triangulation. In someembodiments, the one or more active scanners can include one or moretime-of-flight laser scanners in which a laser rangefinder is used todetermine the distance between a surface, e.g., the body region of anindividual, and the laser emitter by timing the round-trip time of apulse of light. The time-of-flight laser scanner scans the entire fieldof view one point at a time by changing the rangefinders view. In someembodiments, the one or more active scanners can include one or morestructured-light 3D scanners in which a pattern of light is projectedonto the body region of an individual and the deformation of theprojected pattern. Scanners for scanning head, face and/or whole bodyare commercially available (from, e.g., Cyberware, Monterery Calif.;Accurex Measurement Inc., Swathmore, Pa.; 3dMD Atlanta, Ga.;Konica/Minolta, Ramsey, N.J.)

In some embodiments, the one or more digital images are acquired with atleast one passive scanner. A passive scanner relies on detectingreflected ambient radiation, e.g., visible light. Other types of ambientradiation can also be contemplated, including, e.g., infrared light.Non-limiting examples of passive scanners include one or more digitalscameras. In some embodiments, the one or more passive scanners includestereoscopic systems using two video cameras, slightly apart, imagingthe same portion of the body region of the individual in a processtermed stereophotogrammetry. In some embodiments, the passive scannercan include a single camera taking multiple images under differentlighting conditions or from different positions. As an example, thetopography of the body region of an individual can be acquired in apoint-cloud format using a three-dimensional sensing system consistingof two or more digital cameras and one or more projectors connected to apersonal computer. The camera position and shutter can be adjusted tothe body region, which is exposed to structured light, allowing foroptical representation of the surface by a cloud of up to 300,000 pointsin three-dimensional coordinates (see, e.g., Feng et al., Br. J. OralMaxillofac. Surg. (2010) 48:105-109, which is incorporated herein byreference).

In some embodiments, the combination of stereophotogrammetry and 3Dlaser scanner techniques can be combined to generate a three-dimensionalmodel of the body region of an individual (see, e.g., Majid, et al.International Archives of the Photogrammetry, Remote Sensing and SpatialInformation Science. Vol. XXXVII. Part B5. (2008) 805-811; Markiewicz &Bell, Facial Plast. Surg. Clin. N. Am. (2011) 19:655-682; van Heerbeeket al., Rhinology (2009) 47:121-125, which are incorporated herein byreference).

Returning to FIG. 29, block 2700 further optionally includes block 2920.Block 2920 depicts optionally acquiring one or more digital images withone or more of an ultrasound device, a photoacoustic device, a thermalimaging device, a contact scanning device, a magnetic resonance imagedevice, a computed tomography device, a capacitance measuring device,electromyographic device, or other biomedical imaging device. Forexample, skin topographic structures, e.g., wrinkles, can be imagedusing a capacitive device with sensor plates pressed lightly on the skinsurface (see, e.g., Bevilacqua et al., (2006) IEEE InternationalConference on Video and Signal Based Surveillance, pp. 53, which isincorporated herein by reference). For example, electromyography can beused to determine muscle anatomical features and in particular facialmuscle anatomical features (see, e.g., Lapatki et al., J. Neurophysiol.(2006) 95:342-354, which is incorporated herein by reference).

FIG. 30 shows further aspects of the method of FIG. 27. Block 2710optionally include block 3000. Block 3000 depicts optionally creating adigitally rendered model of the wearable injection guide from the one ormore digital images using one or more three-dimensional modelingalgorithms. Block 3000 can optionally include blocks 3010, 3020, and3030. Block 3010 shows optionally using one or more polygonal meshthree-dimensional modeling algorithms to create the digitally renderedmodel of the wearable injection guide. Block 3020 shows optionally usingone or more non-uniform rational basis spline surface modelingalgorithms to create the digitally rendered model of the wearableinjection guide. Block 3030 shows optionally using one or more computeraided design modeling algorithms to create the digitally rendered modelof the wearable injection guide.

Creating a digitally rendered three-dimensional model of the wearableinjection guide from the acquired one or more digital images includesusing a computing device and appropriate software or instructions tocreate the digitally rendered wearable injection guide. In someembodiments, the acquired one or more digital images are brought into acomputing device that is capable of aligning or registering the imagesinto a common coordinate system and then integrating the images into asingle three-dimensional model.

In some embodiments, the active or passive scanners may produce pointclouds of data that are reconstructed using one or morethree-dimensional modeling algorithms to form a digitally rendered modelof the wearable injection guide. One or more modeling programs can beused for this purpose. Non-limiting examples of types of modelingprograms include polygonal mesh three-dimensional modeling programs,non-uniform rational basis spline (NURBS) surface modeling programs, oreditable feature-based computer aided design (CAD) modeling programs. Insome embodiments, the data may be modeled using a first modelingapproach, for example, a NURBS based modeling program and furtherrefined using a second modeling approach, for example, a CAD-basedmodeling program. Numerous software programs are available forgenerating three-dimensional models from scanned images. For example,non-limiting examples of CAD/CAM software programs applicable to medicalimaging include Amira (Visage Imaging GmbH, Berlin Germany); Analyze(AnalyzeDirect, Inc, Overland Park, Kans.); iNtellect Cranial NavigationSystem (Stryker, Freiburg, Germany); iPlan (BrainLab, Westchester,Ill.); Maxilim (Medicim, Bruges Belgium), Mimics, SurgiCase CMF, andSimPlant OMS (Materialise, Leuven, Belgium); Voxim (IVS Solutions,Chemnitz, Germany), 3dMD (Atlanta, Ga.); Alma3D (Alma IT Systems,Barcelona, Spain); and ImageJ (National Institutes of Health, Boston,Mass.) (see, e.g., Markiewicz & Bell, Facial Plast. Surg. Clin. N. Am.(2011) 19:655-682, which is incorporated herein by reference). Facialfeature extraction can be acquired using one or more of an active shapemodel algorithm (see, e.g., Sun & Xie, 11^(th) IEEE InternationalConference on Communication Technology Proceedings, (2008) pp. 661-664;Zheng & Yang IEEE Proceedings of the Seventh International conference onMachine Learning and Cybernetics, (2008) pp. 2841-2845, which areincorporated herein by reference). Other software packages capable ofgenerating a digitally rendered model of the wearable injection guidefrom one or more digital images of a body region of an individual can beused for this purpose. Additional approaches for generatingthree-dimensional models are described in Bernardini & RushmeierComputer Graphics Forum (2002) 21:149-172;

FIG. 31 depicts further aspects of the method of FIG. 27. FIG. 31illustrates that in some embodiments, block 2720 can optionally includeblock 3100. Block 3100 depicts optionally adding the one or moredigitally rendered fiducials in a treatment pattern. In someembodiments, the one or more digitally rendered fiducials are added tothe digitally rendered model of the wearable injection guide at one ormore locations independent of the location of an injection site. Forexample, one or more digitally rendered fiducials can be added anywhereon the model to provide general treatment parameters for use with thewearable injection guide. In some embodiments, the one or more digitallyrendered fiducials are added to the digitally rendered model of thewearable injection guide in a treatment pattern such that the one ormore fiducials are indicative of an injection site (e.g., crosshairs)and/or at least one treatment parameter indicated at that injection site(e.g., dosage of an injectable agent). Block 3100 optionally includesblocks 3110 and 3120. Block 3110 depicts optionally adding the one ormore digitally rendered fiducials in a treatment pattern specific to theindividual. Block 3120 depicts adding the one or more digitally renderedfiducials in a treatment pattern that is part of a treatment regimen.

Block 2720 of FIG. 31 can optionally include blocks 3130, 3140, 3150,and 3160. Block 3130 depicts optionally adding one or more digitallyrendered fiducials indicative of at least one injectable agent to beinjected at the corresponding one or more fiducials on the wearableinjection guide. For example, one or more digitally rendered fiducialsindicative of at least one of an injectable agent, e.g., neurotoxin,subcutaneous volume enhancer, dermal filler, insulin, hormone,chemotherapeutic, antimicrobial, or other biological agent, can be addedto the digitally rendered model of the wearable injection guide. Addingone or more digitally rendered fiducials indicative of other injectableagents not explicitly described herein is also contemplated. Block 3140depicts optionally adding one or more digitally rendered fiducialsindicative of at least one dosage of at least one injectable agent to beinjected at the corresponding one or more fiducials on the wearableinjection guide. For example, one or more digitally rendered fiducialscan be added to the digitally rendered model of the wearable injectionguide indicating the units of botulinum toxin or milliliters of collagenfiller, for example, to be injected at any given injection site. Block3150 shows optionally adding one or more digitally rendered fiducialsindicative of at least one needle injection angle for the at least oneinjectable agent to be injected at the corresponding one or morefiducials on the wearable injection guide. For example, one or moredigitally rendered fiducials can be added to the digitally renderedmodel of the wearable injection guide indicating that the injectionneedle should be injected at 90 degrees or less relative to the skinsurface of the body region. Block 3160 shows optionally adding one ormore digitally rendered fiducials indicative of at least one needleinjection depth for at least one injectable agent to be injected at thecorresponding one or more fiducials on the wearable injection guide. Forexample, one or more digitally rendered fiducials can be added to thedigitally rendered model of the wearable injection guide indicatingwhether the injection needle should be injected into the epidermal,dermal, subcutaneous, or intramuscular portions of the skin. In anotherexample, one or more digitally rendered fiducials can be added to thedigitally rendered model of the wearable injection guide indicating thatthe injection needle should be injected 2-3 mm or 4-10 mm or deeper intothe underlying tissue of the body region. Needle injection depth isdependent upon the type of injectable agent being injected and the skinthickness at any given part of the body, as described previously herein.In some embodiments, the one or more digitally rendered fiducials can beadded to at least a portion of the digitally rendered model of thewearable injection guide that is near or coincident with a treatmentarea on the corresponding body region of the individual.

FIG. 32 illustrates further aspects of the method of FIG. 27. FIG. 32illustrates that in some embodiments, block 2720 can optionally includeblocks 3200, 3210, and 3220. Block 3200 shows optionally adding the oneor more digitally rendered fiducials indicative of the at least onetreatment parameter to the digitally rendered model of the wearableinjection guide from a database of stored treatment parameters. Thedatabase of stored treatment parameters can include treatment options,e.g., injectable agents, for a given condition as well as dosinginformation and information regarding needle penetration and needle sizespecific for any given injectable agent. In some embodiments, thedatabase of stored treatment parameters can include treatment optionsspecific to the individual, e.g., previously used injectable agents,dosages, and injection depth. In some embodiments, the database ofstored treatment parameter can include a medical history of anindividual, e.g., allergies, age, skin properties, medical condition,and other medical history relevant to the injection treatment regimen.The medical history can be used by the physician or other practitionerto plan an individual's treatment regimen such that the appropriatedigitally rendered fiducials outlining that plan are added to thedigitally rendered model of the wearable injection guide.

Block 3210 depicts adding the one or more digitally rendered fiducialsautomatically based on computational analysis of the acquired one ormore digital images of the body region. The computational analysis caninclude a comparison of the one or more digital images of the bodyregion with stored data that includes images of standard, normal orideal body regions or previously captured images of the body region ofthe individual. In some embodiments, the stored data includes idealizedaesthetics of a female or male face (see, e.g., Carruthers et al.,Plast. Reconstr. Surg. (2008) 121 (Suppl):5S-30S, which is incorporatedherein by reference). In some embodiments, the stored data includenormalized skin characteristics based on age or other demographics (see,e.g., Wolff et al., Fertil. Steril. (2011) 95:658-662, which isincorporated herein by reference). In some embodiments, the one or moredigitally rendered fiducials can be added automatically to the digitallyrendered model of the wearable injection guide by a computing devicebased on data from the database of stored treatment parameters. In someembodiments, the computational analysis can include algorithms forpredicting the outcome of a particular treatment regimen. For example,the computational analysis may be used to show an individual via adisplay, e.g., a computer monitor, how a given facial feature, e.g.,nasolabial folds, will change in response to injection of an injectableagent, e.g., a dermal filler.

Returning to FIG. 32, Block 3220 shows optionally adding the one or moredigitally rendered fiducials indicative of the at least one treatmentparameter to digitally rendered model of the wearable injection guidewith a user input device. The user input device can include a keyboardor interactive display panel. In some embodiments, the user input deviceis a keyboard in communication with the computing device running the oneor more three-dimensional modeling algorithms to create the digitallyrendered model of the wearable injection guide. In some embodiments, theuser input device is a wireless device, e.g., a cell phone or otherhandheld device, capable of wirelessly adding one or more digitallyrendered fiducials to the digitally rendered model of the wearableinjection guide. In some embodiments, the one or more digitally renderedfiducials indicative of at least one treatment parameter can be added bya physician or other practitioner using an input device based onconsulting data from a database of stored treatment parameters. In someembodiments, the one or more digitally rendered fiducials can be addedbased on preferences of the individual.

FIG. 33 shows further aspects of the method of FIG. 27. FIG. 33 showsoptionally including block 3300. Block 3300 depicts optionallydeveloping a treatment regimen specific to the individual based oncomputational analysis of the one or more digital images of the bodyregion of the individual, the treatment regimen including at least onetreatment parameter, the at least one treatment parameter represented byone or more digitally rendered fiducials on the digitally rendered modelof the wearable injection guide.

FIG. 34 shows further aspects of the method of FIG. 27. FIG. 34 showsoptionally including blocks 3400, 3410, and 3420. Block 3400 depictsoptionally acquiring the one or more digital images of the body regionof the individual in at least one first expression state and at leastone second expression state. Block 3410 depicts optionally comparing theone or more digital images of the body region of the individual in theat least one first expression state and the at least one secondexpression state to determine a treatment regimen. Block 3420 depictsoptionally adding one or more digitally rendered fiducials to thedigitally rendered model of the wearable injection guide based on thetreatment regimen, the digitally rendered model of the wearableinjection guide created from the one or more digital images of the bodyregion of the individual in the at least one first expression state orthe at least one second expression state.

Block 3400 of FIG. 34 depicts acquiring one or more digital images ofthe body region of an individual in at least one first expression stateand at least one second expression state. For example, one or moreimages of the topography of a body region of an individual's face can beacquired while the individual is in a first expression state, e.g., in arelaxed state, and used to reveal lines or wrinkles present on theindividual's face in the first expression state. One or more images ofthe topography of the individual's face are acquired in a secondexpression state, e.g., a tensed or animated state. Non-limitingexamples of tensed or animated states include laughing, smiling,frowning, grimacing or other non-relaxed states of the individual'sface. The one or more images of the topography of the individual's facein the second expression state, e.g., the animated state, can be used toreveal additional lines or wrinkles present on the individual's face inthe second expression state relative to the first expression state,e.g., the relaxed state. For example, the one or more images of theindividual's face can be acquired while the individual is frowning andgenerating associated frown-line/wrinkles (glabellar lines) between theeyebrows. As another example, the one or more images of the body regionof the individual's face can be acquired while the individual is smilingand generating laugh lines (nasolabial folds) and/or crow's feet nearthe eyes.

Returning to block 3410 of FIG. 34, in some embodiments, comparing theone or more digital images of the body region of the individual in theat least one first expression state and the at least one secondexpression state to determine a treatment regimen includes overlayingthe one or more digital images in the first expression state and the oneor more digital images in the second expression state to identify one ofmore areas of the body region in need of treatment. For example, the oneor more images of the topography of an individual's face in a firstexpression state, e.g., a relaxed state, are overlayed with the one ormore images of the topology of an individual's face in a secondexpression state, e.g., an animated state. In this manner, areas in needof treatment, e.g., frown lines between the eye brows or smile linesaround the mouth, can be identified and placed onto the digitallyrendered model of the wearable injection guide and viewed by thephysician or other practitioner. The treatment regimen with at least onetreatment parameter can then be formulated based on the treatment need.Accordingly, one or more digitally rendered fiducials indicative of thetreatment parameters can be added either automatically by the computingdevice or by a physician, other practitioner, or the individual to thedigitally rendered model of a wearable injection guide. The digitallyrendered model of the wearable injection guide can be created from theone or more digital images in the first expression state, the one ormore digital images in the second expression state, or from somecombination of digital images.

FIG. 35 shows further aspects of the method of FIG. 27. Block 3500depicts optionally adding one or more digitally rendered alignment marksto the digitally rendered model of the wearable injection guidecorresponding to one or more reference points on the body region of theindividual. Block 3500 optionally includes block 3510. Block 3510depicts optionally digitally overlaying the one or more digitallyrendered alignment marks on the digitally rendered model of the wearableinjection guide with one or more reference points identified in the oneor more digital images of the body region of the individual. Forexample, the one or more digital images of the body region may includeone or more images of topographical landmarks, non-limiting examples ofwhich include skin pigmentation, pigmented areas such as moles orfreckles, scars, blemishes, tattoos, subsurface blood vessels,anatomical features or any other topographical landmarks associated withthe body region of the individual that can be used as reference pointsfor aligning the wearable injection guide onto the body region. One ormore digitally rendered alignment marks are added to the digitallyrendered model of the wearable injection at or near the images of theone or more reference points.

Block 3520 of FIG. 35 depicts optionally adding one or more digitallyrendered injection needle access regions to the digitally rendered modelof the wearable injection guide. In some embodiments, adding the one ormore digitally rendered injection needle access regions to the digitallyrendered model of the wearable injection guide can include adding adigitally rendered opening in the model which when manufactured willresult in a hole in the wearable injection guide of appropriate diameterfor insertion of an injection needle. In some embodiments, adding one ormore digitally rendered injection needle access regions to the digitallyrendered model of the wearable injection guide can include decreasingthe thickness of specific portions of the model which when manufacturedwill result in specific portions of the wearable injection guide thatare more easily penetrated by an injection needle. In some embodiments,adding the one or more digitally rendered injection needle accessregions to the digitally rendered model of the wearable injection guidecan include indicating use of a material with reduced hardness inspecific portions of the model which when manufactured will result inspecific portions of the wearable injection guide that are more easilypenetrated by an injection needle. Block 3520 optionally includes block3530. Block 3530 shows optionally adding the one or more digitallyrendered injection needle access regions proximal to or coincident withat least one of the one or more digitally rendered fiducials indicativeof the at least one treatment parameter.

FIG. 36 illustrates further aspects of the method of FIG. 27. FIG. 36depicts block 2730 forming the wearable injection guide from thedigitally rendered model of the wearable injection guide optionallyincluding blocks 3600, 3610, 3620, 3630, and 3640. Block 3600 showsoptionally forming the wearable injection guide from the digitallyrendered model of the wearable injection guide using one or more of anadditive manufacturing process or a subtractive manufacturing process.Block 3610 shows optionally forming the wearable injection guide usingstereolithography. Block 3620 shows optionally forming the wearableinjection guide using laser scintering. Block 3630 shows optionallyforming the wearable injection guide using three-dimensional printing.Additional non-limiting examples of methods for generating athree-dimensional structure from digitized information include fuseddeposition modeling, polyjet, vacuum casting, reaction injectionmolding, or injection molding. Block 3640 shows optionally forming thewearable injection guide from one or more of acrylic, nylon, plastic,ceramic, resin, rubber, epoxy, thermoplastic, photopolymer,polyurethane, latex or silicone. The type of material used for formingthe wearable injection guide is dependent upon the method used to formthe wearable injection guide and the desired properties, e.g., rigidity,transparency, and/or porosity, of the final product. Exemplary materialsand methods for forming a wearable injection guide usingstereolithography, laser scintering or three-dimensional printing aswell as other methods for forming a wearable injection guide fromdigitally rendered model of the wearable injection guide are describedherein.

In some embodiments, the wearable injection guide is formed using anadditive manufacturing process. Additive manufacturing refers to a classof manufacturing process in which a three-dimensional object is built byadding layers of material upon one another. Other terms include layeredmanufacturing, direct digital manufacturing, or solid freeformfabrication. Non-limiting examples of additive manufacturing processesinclude liquid-based processes, e.g., stereolithography, jettedphotopolymer, and ink jet printing; powder-based processes, e.g.,selective laser sintering, direct metal laser sintering, andthree-dimensional printing; and solid-based processes, e.g., laminatedobject manufacturing, fused deposition modeling. In some embodiments,the wearable injection guide is formed using a subtractive manufacturingprocess. Subtractive manufacturing refers to a class of manufacturingprocess in which a three-dimensional object is built by cutting awaymaterial. Non-limiting examples of subtractive manufacturing processesinclude machining, milling, turning, and drilling. Other non-limitingexamples of manufacturing processes include molding, e.g., blow molding,injection molding, or thermoforming; and casting, e.g., centrifugalcasting, die casting, sand casting, shell mold casting.

In some embodiments, the wearable injection guide is generated usingstereolithography using one or more optically-curable photopolymers.Non-limiting examples of materials useful for stereolithography includepoly(ethylene glycol) 1500, Accura 60, Accura 25, Accura Xtreme, Somos9420, Somos 11122, Somos 18420, Somos DMX, Rigi2200,TuskXC2700T/Tusk2700W, Nano5000, Flex45, Flex65, Flex70B, Flex 80,Protogen White. Other non-limiting examples of stereolithography includethree-dimensional printing (3D printing), optical fabrication,photo-solidification, solid free-form fabrication, and solid imaging.

In some embodiments, the wearable injection guide can be generated by 3Dprinting using an inkjet technology, e.g., PolyJet™ (from Objet Ltd) inwhich photopolymer materials are jetted in ultra-thin layers onto abuild tray and cured layer by layer with UV light. Non-limiting examplesof materials for use in generating a wearable injection guide usinginkjet technology include Fullcure 720, VeroWhite, VeroBlack, VeroBlue,and VeroGray for rigid structures; Durus for semi-flexible structures;and Tango Elastomers for rubber-like structures. Other examples of 3Dprinters include ProJet and ZPrinters available from 3D SystemsCorporation, Rock Hill S.C. and Freeform Pico, Asiga, Anaheim Hills,Calif.

In some embodiments, the wearable injection guide is generated usingselective laser sintering in which a high power laser, e.g., a carbondioxide laser, is used to fuse small particles of plastic, metal,ceramic, glass powders, or combinations thereof into a mass that has adesired three-dimensional shape. Non-limiting examples of material foruse in generating a wearable injection guide using laser sinteringinclude polyamide, nylon, carbon, hydroxyapatite, glass filledpolyamide, and alumide.

In some embodiments, the wearable injection guide is generated usingfused deposition modeling. Fused deposition modeling is an extrusionbased three-dimensional modeling process using thermoplastic materials.Non-limiting examples of materials for use in fused deposition modelinginclude the thermoplastics ABS, ABS/F1, polycarbonate, and Ultem 9085.The uPrint SE from Stratasys (Eden Prairie, Minn.) or the DimensionElite 3D printer from Dimension, Inc. (Eden Prairie, Minn.) arenon-limiting examples of systems for fused deposition modeling withthermoplastics that might be appropriate for use in a medical clinic.

Returning to FIG. 36, the method of FIG. 27 can optionally include block3650. Block 3650 depicts optionally forming the wearable injection guideby forming a three-dimensional mold surface from the digitally renderedmodel of the wearable injection guide and using the three-dimensionalmold surface with a moldable material to generate the formed wearableinjection guide. For example, a three-dimensional mold surface of theindividual's face can be fabricated from a thermoplastic material basedon the digitally rendered model of the wearable injection guide. Amoldable material, e.g., latex, can then be poured into or over thethree-dimensional mold surface to generate the formed wearable injectionguide. The three-dimensional mold surface can be used repeatedly togenerate one or more wearable injection guides.

FIG. 37 depicts further aspects of the method of FIG. 27. FIG. 37 showsoptionally including blocks 3700 and 3710 to the method of generating awearable injection guide. Block 3700 illustrates optionally coating atleast a portion of one or more surfaces of the formed wearable injectionguide with at least one agent. For example, the inner surface of awearable injection guide formed from a porous material, e.g., a ceramicor hydroxyapatite, can be coated with one or more agents followingmanufacture and prior to deployment onto the body region of anindividual. Block 3700 optionally includes block 3710. Block 3710 showscoating at least a portion of one or more surfaces of the formedwearable injection guide with at least one of an analgesic,disinfectant, antiseptic, sterilant, or therapeutic agent, examples ofwhich have been described elsewhere herein. For example, a surface ofone or more of the injection needle access regions of the formedwearable injection guide can be coated with lidocaine for use in easingthe pain associated with needle injection.

Block 3720 of FIG. 37 illustrates optionally adding one or moreactivatable injection event indicators to the formed wearable injectionguide. The one or more activatable injection event indicators caninclude one or more of a pressure sensitive material, flowable dye,and/or needle penetrable membrane. Block 3720 optionally includes block3730. Block 3730 shows optionally adding one or more coatings, films,layers, or needle-penetrable reservoirs including the one or moreactivatable injection event indicators. For example, a pressuresensitive film can be added to the outer surface of the wearableinjection guide following manufacture, the pressure sensitive filmconfigured to change color in response to applied pressure accompanyinginsertion of an injection needle through the wearable injection guide.In another example, needle penetrable reservoirs, e.g., bubbles ofneedle penetrable plastic encapsulating a flowable dye, can be fixedinto injection needle access regions, e.g., openings in the rigidmaterial of formed wearable injection guide and release dye in responseto insertion of an injection needle through the injection needle accessregions. In some embodiments, the one or more needle-penetrablereservoirs can further include one or more agents, e.g., one or moreanalgesic, one or more disinfectant, antiseptic or sterilant, and/or oneor more therapeutic agent, non-limiting examples of which have beendescribed elsewhere herein.

FIG. 38 illustrates further aspects of the method of FIG. 27. FIG. 38shows optionally including blocks 3800 and 3820 to the method ofgenerating a wearable injection guide. Block 3800 shows optionallyadding an immobilizing means to the formed wearable injection guide. Insome embodiments, the immobilizing means is used to keep the wearableinjection guide covering a specified portion of the body region duringthe injection process. Block 3810 shows optionally adding one or more ofan adhesive or a body portion-encircling piece to the formed wearableinjection guide as a means of immobilizing the wearable injection guide.Other means of immobilizing the wearable injection guide arecontemplated including but not limited to a sleeve or a clamp. Block3820 shows optionally adding a thermal-regulating mechanism to theformed wearable injection guide. The thermal regulating mechanism can beused to either cool or heat the wearable injection guide. For example,cooling the wearable injection guide prior to, during, and/or afterneedle injection into the underlying tissue can be used to attenuatepain and bruising associated with needle injection. For example, heatingthe wearable injection guide prior to, during and/or after needleinjection into the underlying tissue can be used to dilate bloodvessels, causing the injectable agent to disperse more rapidly followinginjection. The thermal-regulating mechanism can include one or more of aPeltier device or thermochemical agent added to the formed wearableinjection guide. For example, an inner surface of the wearable injectionguide can be impregnated with components of a thermochemical coolingagent, e.g., ammonium nitrate, and activated just prior to deploying thewearable injection guide onto the body region of the individual.

In some embodiments, the method of generating a wearable injection guidefurther includes adding one or more patient identifiers. Block 3830shows optionally adding one or more one or more of a barcode orradiofrequency identification tag to the wearable injection guide. Insome embodiments, the barcode or radiofrequency identification tag canbe added to the digitally rendered model of the wearable injection guideand incorporated into the formed wearable injection guide duringmanufacture. In some embodiments, the barcode or radiofrequencyidentification tag can be added to the formed wearable injection guideafter manufacture.

In some embodiments, the method of FIG. 27 optionally includessterilizing the formed wearable injection guide prior to use. The formedwearable injection guide can be sterilized using any of a number ofmethods including but not limited to heat sterilization, e.g., boilingwater, autoclave; radiation sterilization, e.g., gamma rays, electronbeam processing, x-ray, ultraviolet light; or chemical sterilization,e.g., ethylene oxide, ozone, bleach, glutaraldehyde, formaldehyde,hydrogen peroxide, and silver compounds.

FIG. 39 illustrates a method of generating a wearable injection guidefor an individual. Block 3900 shows acquiring one or more digital imagesof a body region of the individual. In some embodiments, acquiring oneor more digital images of the body region of an individual includesacquiring one or more digital images of a topography of the body regionof the individual. In some embodiments, acquiring the one or moredigital images of the body region of the individual includes acquiringthe one or more digital images with one or more of a camera, activescanner, or passive scanner. In some embodiments, acquiring the one ormore digital images of the body region includes acquiring the one ormore digital images with one or more of an ultrasound device, aphotoacoustic device, a thermal imaging device, a contact scanningdevice, a magnetic resonance imaging device, a computed tomographydevice, a capacitance measuring device, or other biomedical imagingdevice. Block 3910 depicts creating a digitally rendered model of thewearable injection guide from the one or more digital images of the bodyregion of the individual. Any of a number of three-dimensional modelingalgorithms can be used for this purpose, examples of which have beendescribed above herein.

Block 3920 of FIG. 39 depicts adding one or more digitally renderedinjection needle access regions in a treatment pattern to the digitallyrendered model of the wearable injection guide. The one or moredigitally rendered injection needle assess regions can include portionsof the digitally rendered model of the wearable injection that representan opening that transects the digitally rendered model, a reducedthickness in the digitally rendered model, or a reduced hardness in thedigitally rendered model. In some embodiments, adding the one or moredigitally rendered injection needle access regions includes adding oneor more digitally rendered injection needle access regions that transectan inner surface and an outer surface of the digitally rendered model ofthe wearable injection guide at an angle of 90 degrees or at an angleless than 90 degrees. In some embodiments, adding one or more digitallyrendered injection needle access regions includes adding a downwardtapered access surface to at least one of the one or more digitallyrendered injection needle access regions. The downward tapered accesssurface on the formed wearable injection guide can be used to direct aninjection needle to a very specific portion of the injection needleaccess region. In some embodiments, adding the one or more digitallyrendered injection needle access regions includes automatically addingone or more digitally rendered injection needle access regions in atreatment pattern based on computational analysis of the one or moredigital images of the body region of the individual. The computationanalysis includes determining where treatment is needed on the bodyregion and the appropriate pattern of injection needle access regionsneedle to administer that treatment. The one or more digitally renderedinjection needle access regions are added to the digitally renderedmodel of the wearable injection guide in a treatment pattern. In someembodiments, the treatment pattern is generic for a particular conditionor treatment option. In some embodiments, the treatment pattern can bespecific to an individual, patterned to accommodate specific needsand/or anatomical features of the individual. In some embodiments, thetreatment pattern is part of a treatment regimen, the treatment regimenis either a generic treatment regimen or a treatment regimen specificfor an individual.

In some embodiments, the method of FIG. 39 further includes adding oneor more digitally rendered fiducials indicative of at least onetreatment parameter to the digitally rendered model of the wearableinjection guide. The one or more digitally rendered fiducials can beadded proximal to or coincident with the one or more digitally renderedinjection needle access regions.

Returning to FIG. 39, block 3930 illustrates forming the wearableinjection guide from the digitally rendered model of the wearableinjection guide, the formed wearable injection guide including one ormore injection needle access regions in a treatment pattern, the one ormore injection needle access regions corresponding to the one or moredigitally rendered injection needle access regions on the digitallyrendered model of the wearable injection guide. Any of a number ofadditive or subtractive manufacturing processes can be used to form thewearable injection guide, non-limiting examples of which have beendescribed herein.

In some embodiments, the method of FIG. 39 further includes adding oneor more fiducials indicative of at least one treatment parameter to theformed wearable injection guide. The one or more fiducials can be addedproximal to or coincident with the one or more injection needle accessregions on the formed wearable injection guide. In this way, one or morefiducials indicative of at least one treatment parameter can be added tothe wearable injection guide after it has been manufactured, allowingfor changes in the treatment parameters. In some embodiments, thewearable injection guide is reusable with either fixed permanentfiducials or replaceable fiducials, allowing for repeated use of thewearable injection guide and flexibility in the treatment parameters.

FIG. 40 illustrates a method of generating a wearable injection guidefor use on a body region of an individual. Block 4000 depicts acquiringone or more digital images of a body region of the individual. Block4010 depicts creating a digitally rendered three-dimensional moldsurface model of the body region. Block 4020 depicts developing atreatment regimen specific to the individual based on analysis of thedigitally rendered three-dimensional surface model of the body region ofthe individual. Block 4030 depicts adding one or more digitally renderedfiducials indicative of at least one treatment parameter to thedigitally rendered three-dimensional surface model of the body region,the at least one treatment parameter is a component of the treatmentregimen specific to the individual. Block 4040 depicts printing the oneor more digitally rendered fiducials indicative of the at least onetreatment parameter onto a surface of a preformed wearable injectionguide, the preformed wearable injection guide configured to cover atleast a portion of the body region of the individual.

In some embodiments, developing a treatment regimen specific to theindividual based on analysis of the digitally rendered three-dimensionalsurface model of the body region includes having a physician, otherpractitioner, and/or the individual analyze the digitally renderedthree-dimensional surface model on a display, e.g., a computer monitor,decide which treatment regimen and associated treatment parameters areappropriate, and add one or more digitally rendered fiducials to thedigitally rendered three-dimensional surface model representative of thetreatment parameters. In some embodiments, a computing device, e.g., thecomputing device used to create the digitally rendered three-dimensionalmold surface, analyzes the features of the three-dimensional surface andrecommends or automatically adds one or more fiducials indicative of atreatment parameter to the model.

In some embodiments, the one or more digitally rendered fiducials areprinted onto a surface of a preformed wearable injection guide using aninkjet printer configured to print onto three-dimensional objects (see,e.g., Xennia Xanadu, Xannia Technology Ltd., Hertfordshire, UK).

FIG. 41 illustrates aspects of a system for generating a wearableinjection guide for an individual. System 4100 comprises at least oneimage capture device 4110 configured to acquire one or more digitalimages of a body region 4120 of an individual. In the embodimentillustrated in FIG. 41, the body region 4120 is associated with anindividual's face. However, it is contemplated that a body region fromany portion of an individual's body, including the face, torso, abdomen,head, neck, upper extremities, lower extremities, buttocks, or any otherbody region accessible to injection can be imaged for use in generatinga wearable injection guide. The image capture device can include one ormore passive or active scanners, digital cameras, charge-coupled device(CCD), complementary metal oxide semiconductor (CMOS), infrared sensor,or any other device suited to capturing an image of a body region. Othernon-limiting examples of an image capture device include an ultrasounddevice, a photoacoustic device, a thermal imaging device, a contactscanning device, a magnetic resonance imaging device, a computedtomography device, a capacitance measuring device, an electomyographicdevice, or other biomedical imaging devices. The at least one imagecapture device 4110 is further configured to transmit one or more outputsignals having information associated with the one or more digitalimages.

System 4100 of FIG. 41 further comprises a computing device 4130operably linked to at least one image capture device 4110 and includingdisplay monitor 4132. Computing device 4130 includes non-transitorymachine readable media 4135 bearing one or more instructions forgenerating a wearable injection guide from the one or more digitalimages of the body region 4120 of the individual. The non-transitorymachine readable media 4135 bearing one or more instructions forgenerating a wearable injection guide includes one or more instructions4140 for controlling one or more functions of the at least one imagecapture device 4110. In some embodiments, the one or more instructions4140 include one or more instructions for controlling acquisition of theone or more digital images of the body region of the individual with theat least one image capture device. In some embodiments, the one or moreinstructions 4140 can include one or more instructions for turning theimage capture device on/off, one or more instructions for modulating thequality and/or quantity of radiation, e.g., light, projected on theindividual, and one or more instructions for controlling scan speed. Theone or more instructions 4140 can include one or more instructions forcausing movement of the at least one capture image capture device toallow image capture from different positions or angles relative to theindividual.

The non-transitory machine readable media 4135 bearing one or moreinstructions for generating a wearable injection guide includes one ormore instructions 4142 for receiving the one or more output signalshaving information associated with the one or more digital images fromthe at least one image capture device 4110. In some embodiments, the oneor more instructions 4142 for receiving the one or more output signalsincludes one or more instructions for receiving a wired transmissionfrom the at least one image capture device. In some embodiments, the oneor more instructions 4142 for receiving the one or more output signalsincludes one or more instructions for receiving a wireless transmissionfrom the at least one image capture device.

The non-transitory machine readable media 4135 bearing one or moreinstructions for generating a wearable injection guide includes one ormore instructions 4144 for creating a digitally rendered model of thewearable injection guide from the one or more digital images of the bodyregion of the individual. In some embodiments, the one or moreinstructions 4144 for creating the digitally rendered model of thewearable injection guide include one or more instructions associatedwith an algorithm configured to generate a digitally renderedthree-dimensional model based on one or more acquired digital images.Examples of algorithms and programs for three-dimensional modeling havebeen described above herein.

The non-transitory machine readable media 4135 bearing one or moreinstructions for generating a wearable injection guide includes one ormore instructions 4146 for adding one or more digitally renderedfiducials indicative of at least one treatment parameter to thedigitally rendered model of the wearable injection guide. In someembodiments, the one or more instructions 4146 for adding the one ormore digitally rendered fiducials includes one or more instructions foradding the one or more digitally rendered fiducials a user input device,e.g., a keyboard or touchpad associated with the computing device. Insome embodiments, the one or more instructions 4146 for adding thedigitally rendered fiducials includes one or more instructions foradding the one or more digitally rendered fiducials automatically to thedigitally rendered model of the wearable injection guide based onformulating a treatment regimen from a comparison of the acquired one ormore digital images and one or more stored digital images. The storeddigital images can include previous digital images of the individualand/or normative or standard images. The comparison of the acquired oneor more digital images and the one or more stored digital images by, forexample an overlay and/or subtractive process is used to identify areasin need of treatment. Once an area has been identified as an area inneed of treatment, the computing device may automatically add one ormore digitally rendered fiducials to the digitally rendered model in theappropriate injection site locations. In some embodiments, the one ormore instructions 4146 for adding the one or more digitally renderedfiducials are based on an outcome defined by the individual. Forexample, the individual may request enhanced lips or reduced frown linesbased on analysis of the one or more digital images.

The non-transitory machine readable media 4135 bearing one or moreinstructions for generating a wearable injection guide includes one ormore instructions 4148 for generating one or more model output signalshaving information for forming the wearable injection guide from thedigitally rendered model of the wearable injection guide. The one ormore instructions 4148 for generating one or more model output signalcan include instructions for sending the model output signal wirelesslyor by wire. The one or more instructions 4148 may further include one ormore instructions for converting the data file containing theinformation regarding the digitally rendered model of the wearableinjection guide into a format acceptable for transmission to amanufacturing device, e.g., additive manufacturing file (AMF) format orSTL (STereoLithography) format.

System 4100 of FIG. 41 further includes manufacturing device 4150configured to receive the one or more model output signals from thecomputing device 4130 and to form the wearable injection guide 4160 fromthe digitally rendered model of the wearable injection guide, the formedwearable injection guide 4160 including one or more fiducials 4170indicative of the at least one treatment parameter, the one or morefiducials 4170 corresponding to the one or more digitally renderedfiducials on the digitally rendered model of the wearable injectionguide. The manufacturing device 4150 can include one or more of a rapidprototyping device. The manufacturing device 4150 can include astereolithography device, a laser scintering device, and/or a 3Dprinting device. Other non-limiting examples of manufacturing devicesfor use in forming the wearable injection guide include devices capableof fused deposition modeling, polyjetting, vacuum casting, reactioninjection molding, or injection molding.

FIG. 42 illustrates further aspects of a system of FIG. 41. Thenon-transitory machine readable media 4135 bearing one or moreinstructions for generating a wearable injection guide can furtherinclude one or more instructions 4220 for acquiring the one or moredigital images of the body region of the individual with the at leastone image capture device 4110 in at least one first expression state4200 and at least one second expression state 4210; one or moreinstructions 4230 for comparing the one or more digital images 4205 ofthe body region of the individual in the at least one first expressionstate 4200 and the at least one second expression state 4210 todetermine a treatment regimen; and one or more instructions 4240 foradding the one or more digitally rendered fiducials 4250 to thedigitally rendered model of the wearable injection guide 4260 based onthe treatment regimen.

FIG. 43 illustrates aspects of an article of manufacture for use ingenerating a wearable injection guide. Article of manufacture 4300includes non-transitory machine readable media 4310 bearing one or moreinstructions for generating a wearable injection guide for administeringan injectable agent to an individual. The non-transitory machinereadable media stores instructions and/or data for use in generating awearable injection guide. In an embodiment, non-transitory machinereadable media 4310 can be computer readable media. In an embodiment,non-transitory machine readable media 4310 can be recordable-type media.Computer readable media may also be recordable-type media, and thequalities of being “computer readable” and “recordable-type” should notbe construed as being mutually exclusive, though in some cases acomputer readable media may not be a recordable-type media, and viceversa. Machine readable media include volatile and nonvolatile,removable and non-removable media implemented in any method ortechnology for storage of information such as machine readableinstructions, data structures, program modules, or other data.Non-transitory machine readable media include, but are not limited to,random-access memory (RAM), read-only memory (ROM), electricallyerasable programmable read-only memory (EEPROM), flash memory, or othermemory technology, CD-ROM, digital versatile disks (DVD), or otheroptical disk storage, magnetic cassettes, magnetic tape, magnetic diskstorage, or other magnetic storage devices, or any other media which canbe used to store the desired information. In a further embodiment,computer storage media may include a group of computer storage mediadevices. In an embodiment, machine readable media may include aninformation store. In an embodiment, an information store may include aquantum memory, a photonic quantum memory, or atomic quantum memory.Combinations of any of the above may also be included within the scopeof non-transitory machine readable media.

The one or more instructions of the non-transitory machine readablemedia include one or more instructions 4320 for controlling acquisitionof the one or more digital images of a body region of the individualwith at least one image capture device; one or more instructions 4330for receiving one or more output signals having information associatedwith the one or more digital images of the body region from the at leaston image capture device; one or more instructions 4340 for creating adigitally rendered model of the wearable injection guide from the one ormore digital images of the body region of the individual; one or moreinstructions 4350 for generating a treatment regimen for the individualbased on the one or more digital images of the body region; one or moreinstructions 4360 for adding one or more digitally rendered fiducialsindicative of at least one treatment parameter of the treatment regimento the digitally rendered model of the wearable injection guide; and oneor more instructions 4370 for generating one or more model outputsignals having information for manufacturing the wearable injectionguide from the digitally rendered model of the wearable injection guide.

The state of the art has progressed to the point where there is littledistinction left between hardware, software, and/or firmwareimplementations of aspects of systems; the use of hardware, software,and/or firmware is generally (but not always, in that in certaincontexts the choice between hardware and software can becomesignificant) a design choice representing cost vs. efficiency tradeoffs.There are various vehicles by which processes and/or systems and/orother technologies described herein can be effected (e.g., hardware,software, and/or firmware), and that the preferred vehicle will varywith the context in which the processes and/or systems and/or othertechnologies are deployed. For example, if an implementer determinesthat speed and accuracy are paramount, the implementer may opt for amainly hardware and/or firmware vehicle; alternatively, if flexibilityis paramount, the implementer may opt for a mainly softwareimplementation; or, yet again alternatively, the implementer may opt forsome combination of hardware, software, and/or firmware. Hence, thereare several possible vehicles by which the processes and/or devicesand/or other technologies described herein can be effected, none ofwhich is inherently superior to the other in that any vehicle to beutilized is a choice dependent upon the context in which the vehiclewill be deployed and the specific concerns (e.g., speed, flexibility, orpredictability) of the implementer, any of which may vary. Opticalaspects of implementations will typically employ optically-orientedhardware, software, and or firmware.

In some implementations described herein, logic and similarimplementations can include software or other control structures.Electronic circuitry, for example, may have one or more paths ofelectrical current constructed and arranged to implement variousfunctions as described herein. In some implementations, one or moremedia can be configured to bear a device-detectable implementation whensuch media hold or transmit a device detectable instructions operable toperform as described herein. In some variants, for example,implementations can include an update or modification of existingsoftware or firmware, or of gate arrays or programmable hardware, suchas by performing a reception of or a transmission of one or moreinstructions in relation to one or more operations described herein.Alternatively or additionally, in some variants, an implementation caninclude special-purpose hardware, software, firmware components, and/orgeneral-purpose components executing or otherwise invokingspecial-purpose components. Specifications or other implementations canbe transmitted by one or more instances of tangible transmission mediaas described herein, optionally by packet transmission or otherwise bypassing through distributed media at various times.

Alternatively or additionally, implementations can include executing aspecial-purpose instruction sequence or invoking circuitry for enabling,triggering, coordinating, requesting, or otherwise causing one or moreoccurrences of virtually any functional operations described herein. Insome variants, operational or other logical descriptions herein can beexpressed as source code and compiled or otherwise invoked as anexecutable instruction sequence. In some contexts, for example,implementations can be provided, in whole or in part, by source code,such as C++, or other code sequences. In other implementations, sourceor other code implementation, using commercially available and/ortechniques in the art, can be compiled/implemented/translated/convertedinto a high-level descriptor language (e.g., initially implementingdescribed technologies in C or C++ programming language and thereafterconverting the programming language implementation into alogic-synthesizable language implementation, a hardware descriptionlanguage implementation, a hardware design simulation implementation,and/or other such similar mode(s) of expression). For example, some orall of a logical expression (e.g., computer programming languageimplementation) can be manifested as a Verilog-type hardware description(e.g., via Hardware Description Language (HDL) and/or Very High SpeedIntegrated Circuit Hardware Descriptor Language (VHDL)) or othercircuitry model which may then be used to create a physicalimplementation having hardware (e.g., an Application Specific IntegratedCircuit). Those skilled in the art will recognize how to obtain,configure, and optimize suitable transmission or computational elements,material supplies, actuators, or other structures in light of theseteachings.

The foregoing detailed description has set forth various embodiments ofthe devices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, or examples can be implemented,individually and/or collectively, by a wide range of hardware, software,firmware, or virtually any combination thereof. In one embodiment,several portions of the subject matter described herein can beimplemented via Application Specific Integrated Circuits (ASICs), FieldProgrammable Gate Arrays (FPGAs), digital signal processors (DSPs), orother integrated formats. However, some aspects of the embodimentsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, the mechanisms ofthe subject matter described herein are capable of being distributed asa program product in a variety of forms, and that an illustrativeembodiment of the subject matter described herein applies regardless ofthe particular type of signal bearing medium used to actually carry outthe distribution. Examples of a signal bearing medium include, but arenot limited to, the following: a recordable type medium such as a floppydisk, a hard disk drive, a Compact Disc (CD), a Digital Video Disk(DVD), a digital tape, a computer memory, etc.; and a transmission typemedium such as a digital and/or an analog communication medium (e.g., afiber optic cable, a waveguide, a wired communications link, a wirelesscommunication link (e.g., transmitter, receiver, transmission logic,reception logic, etc.), etc.).

In a general sense, the various embodiments described herein can beimplemented, individually and/or collectively, by various types ofelectro-mechanical systems having a wide range of electrical componentssuch as hardware, software, firmware, and/or virtually any combinationthereof and a wide range of components that may impart mechanical forceor motion such as rigid bodies, spring or torsional bodies, hydraulics,electro-magnetically actuated devices, and/or virtually any combinationthereof. Consequently, as used herein “electro-mechanical system”includes, but is not limited to, electrical circuitry operably coupledwith a transducer (e.g., an actuator, a motor, a piezoelectric crystal,a Micro Electro Mechanical System (MEMS), etc.), electrical circuitryhaving at least one discrete electrical circuit, electrical circuitryhaving at least one integrated circuit, electrical circuitry having atleast one application specific integrated circuit, electrical circuitryforming a general purpose computing device configured by a computerprogram (e.g., a general purpose computer configured by a computerprogram which at least partially carries out processes and/or devicesdescribed herein, or a microprocessor configured by a computer programwhich at least partially carries out processes and/or devices describedherein), electrical circuitry forming a memory device (e.g., forms ofmemory (e.g., random access, flash, read only, etc.)), electricalcircuitry forming a communications device (e.g., a modem, communicationsswitch, optical-electrical equipment, etc.), and/or any non-electricalanalog thereto, such as optical or other analogs. Those skilled in theart will also appreciate that examples of electro-mechanical systemsinclude but are not limited to a variety of consumer electronicssystems, medical devices, as well as other systems such as motorizedtransport systems, factory automation systems, security systems, and/orcommunication/computing systems. Electro-mechanical as used herein isnot necessarily limited to a system that has both electrical andmechanical actuation except as context may dictate otherwise.

In a general sense, the various aspects described herein can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, and/or any combination thereof and can beviewed as being composed of various types of “electrical circuitry.”Consequently, as used herein “electrical circuitry” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of memory (e.g., random access, flash, readonly, etc.)), and/or electrical circuitry forming a communicationsdevice (e.g., a modem, communications switch, optical-electricalequipment, etc.). The subject matter described herein can be implementedin an analog or digital fashion or some combination thereof.

At least a portion of the devices and/or processes described herein canbe integrated into an image processing system. A typical imageprocessing system generally includes one or more of a system unithousing, a video display device, memory such as volatile or non-volatilememory, processors such as microprocessors or digital signal processors,computational entities such as operating systems, drivers, applicationsprograms, one or more interaction devices (e.g., a touch pad, a touchscreen, an antenna, etc.), control systems including feedback loops andcontrol motors (e.g., feedback for sensing lens position and/orvelocity; control motors for moving/distorting lenses to give desiredfocuses). An image processing system can be implemented utilizingsuitable commercially available components, such as those typicallyfound in digital still systems and/or digital motion systems.

At least a portion of the devices and/or processes described herein canbe integrated into a data processing system. A data processing systemgenerally includes one or more of a system unit housing, a video displaydevice, memory such as volatile or non-volatile memory, processors suchas microprocessors or digital signal processors, computational entitiessuch as operating systems, drivers, graphical user interfaces, andapplications programs, one or more interaction devices (e.g., a touchpad, a touch screen, an antenna, etc.), and/or control systems includingfeedback loops and control motors (e.g., feedback for sensing positionand/or velocity; control motors for moving and/or adjusting componentsand/or quantities). A data processing system can be implementedutilizing suitable commercially available components, such as thosetypically found in data computing/communication and/or networkcomputing/communication systems.

One skilled in the art will recognize that the herein describedcomponents (e.g., operations), devices, objects, and the discussionaccompanying them are used as examples for the sake of conceptualclarity and that various configuration modifications are contemplated.Consequently, as used herein, the specific exemplars set forth and theaccompanying discussion are intended to be representative of their moregeneral classes. In general, use of any specific exemplar is intended tobe representative of its class, and the non-inclusion of specificcomponents (e.g., operations), devices, and objects should not be takenlimiting.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely exemplary, and that in fact many other architectures can beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected,” or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable,” to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically mateable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations are not expressly set forth herein for sakeof clarity.

In some instances, one or more components can be referred to herein as“configured to,” “configured by,” “configurable to,” “operable/operativeto,” “adapted/adaptable,” “able to,” “conformable/conformed to,” etc.Those skilled in the art will recognize that such terms (e.g.“configured to”) can generally encompass active-state components and/orinactive-state components and/or standby-state components, unlesscontext requires otherwise.

While particular aspects of the present subject matter described hereinhave been shown and described, changes and modifications can be madewithout departing from the subject matter described herein and itsbroader aspects and, therefore, the appended claims are to encompasswithin their scope all such changes and modifications as are within thetrue spirit and scope of the subject matter described herein. Terms usedherein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

PROPHETIC EXAMPLES Example 1 A Wearable Injection Guide for Treating aFacial Region of an Individual with Botulinum Toxin

Construction and use of a rigid wearable injection guide are described.The wearable injection guide is constructed of a rigid materialsubstantially impenetrable to an injection needle and including one ormore injection needle access regions. The wearable injection guide isformed based on a digitally rendered model of the wearable injectionguide and is used for guiding injection of botulinum toxin into wrinklesassociated with a forehead region of an individual.

A digitally rendered model of a wearable injection guide is generatedfrom one or more digital images of the body region of the individual'sface, including at least a portion of the individual's forehead.Briefly, two charge-coupled device cameras and a projector connected toa computer are used to scan the body region of the individual's face asdescribed in Feng et al. Brit. J. Oral Maxillofacial Surg. (2010)48:105-109, which is incorporated herein by reference. The individual'sface is exposed to structured light to collect an optical representationof the body region by a point cloud of up to 300,000 points inthree-dimensional coordinates. The three-dimensional coordinates areacquired by the computer and used to construct a digitally renderedmodel of the wearable injection guide using a CAD/CAM software package,e.g., Geomagic Studio (Morrisville, N.C.).

A triangular pattern of 9 to 13 digitally rendered injectionneedle-access regions are added to the forehead region of the digitallyrendered model of the wearable injection guide. The 9 to 13 digitallyrendered injection needle-access regions correspond to openings in therigid material of the formed wearable injection guide through whichinjection needles can be inserted for injection of botulinum toxin intothe underlying tissue of the body region once the formed wearableinjection guide is deployed on the surface of the individual's face. Thedigitally rendered injection needle-access regions are placed on thedigitally rendered model of the wearable injection guide in portions ofthe guide corresponding to the following portions of the individual'sface: 0.5 centimeters below the lateral brow; in the midpupillary line,halfway between the eyebrow and the frontal scalp on each side of themodel; at the vertex of the forehead; at the midline just below themeeting of the eyebrows; at the midline of the forehead, halfway betweenthe nasal radix and the vertex of the scalp; and over the corrugators,approximately 1 centimeter above the medial portion of the each eyebrow(see, e.g., Bain et al., Aesthetic Surg. J. (2006) 26:617-619, which isincorporated herein by reference).

One or more digitally rendered fiducials indicating the prescribed doseof botulinum toxin for injection at each of the injection needle accessregions is added to the digitally rendered model of the wearableinjection guide by a physician or other practitioner using a user inputdevice, e.g., a keyboard or touchpad associated with the computer.Typical dosages per injection site range from 1 to 6 units of botulinumtoxin. One unit is defined as the median lethal dose in mice. The medianlethal dose in humans is estimated at 3500 U. The physician or otherpractitioner decides how many units should be injected per injectionsite based on the depth and/or intensity of the wrinkles on theindividual's forehead.

The wearable injection guide including one or more injection needleaccess regions and one or more fiducials indicative of at least onetreatment parameter is formed from the digitally rendered model of thewearable injection guide using a commercially available 3D printer. Anexample of a 3D printer appropriate for a physician's office, forexample, includes the uPrint SE system (from Stratasys, Eden Prairie,Minn.). In this example, software associated with the 3D printer systemconverts an STL format file containing data regarding the digitallyrendered model of the wearable injection guide into deposition pathsthat guide the extrusion head of the printer, printing the wearableinjection guide layer by layer. The wearable injection guide, with anoverall thickness of 3 mm, is produced from a thermoplastic material,e.g., acrylonitrile butadiene styrene (ABS). Several wearable injectionguides specifically designed for the individual can be printed and usedat subsequent treatment appointments. Similarly, the information used toform the wearable injection guide can be saved for printing additionalguides in the future.

The physician or other practitioner prepares the botulinum toxin, e.g.,botulinum toxin A (BOTOX®), for injection. A 100 Unit vial of BOTOX®,which has been stored frozen, is thawed and mixed with 2.5-4.0milliliters (ml) of 0.9% non-preserved sterile saline solution to createa final concentration of 40-25 Units/ml. Saline including a preservativeor water for injection (WFI) can also be used for this purpose.

The inner surface of the wearable injection guide is coated with a thinlayer of petroleum jelly (e.g., Vaseline®) and the wearable injectionguide is placed on the face of the individual. In some instances,depending on the sensitivity/pain threshold of the individual, the innersurface of the wearable injection guide can also be coated with a layerof anesthetic cream, e.g., eutectic mix of local anesthetics lidocaine(2.5%) and prilocaine (2.5%). Alternatively, the wearable injectionguide can be cooled in a refrigerator to 5-10 degrees centigrade priorto placement on the individual's face as a means of reducing the pain ofinjection and/or post-injection swelling. A 1 or 3 ml syringe with a30-gauge needle is used for injection, although needles ranging in gaugefrom 27 to 32 can be used for this purpose. Appropriate length needlesfor this purpose include ½ (12.7 mm) inch, 5/16 inch (8 mm) and 3/16inch (5 mm) lengths. The needles are inserted through injection needleaccess regions and botulinum toxin is injected through the injectionneedles and into the underlying muscle of the forehead.

The individual may return from 30 to 120 days for a repeat course ofinjections, depending upon the sustainability of the treatment. Inrepeat visits, the same wearable injection guide may be used with thesame injection needle access regions and fiducials, if appropriate.Alternatively, the physician or other practitioner may alter thefiducials indicating new treatment parameters. Alternatively, thephysician or other practitioner may choose to print a new wearableinjection guide with or without modifications to the pattern ofinjection needle access regions and/or the one or more fiducialsindicative of a treatment parameter.

Alternative patterns of injection needle access regions can beconsidered depending upon the region of the face in need of treatment.For example, the treatment pattern can include one or more injectionneedle access regions arranged for treatment of the glabella. In thisinstance, the glabella region can be divided into the superior-lateralregion and the central and inferomedial regions. The one or moreinjection needle access regions are arranged in the superior-lateralregion over the medial portion of the corrugators muscle near itsorigin. One or more additional injection needle access regions arearranged over the mid portion of the muscle belly. Each of these sitesincludes one or more fiducials indicating 5 units of botulinum toxin. Inaddition, one or more injection needle access regions are arranged overthe middle of the procerus muscle belly which is slightly off midline atthe levels of the superior orbital rims. This pattern is repeated onother side. Each of these sites is includes one or more fiducialsindicating 6 units of botulinum toxin. One or more injection needleaccess region is added over the depressor supercilli muscle, which isapproximately 1 centimeter above the medial canthal tendon on bothsides. Each of these sites includes one or more fiducials indicating 3units of botulinum toxin.

In another example, the treatment pattern can include one or moreinjection needle access regions arranged for treatment of periorbitalwrinkles, i.e., “crow's feet,” with the one or more injection needleaccess regions placed approximately 1 centimeter lateral to the lateralcanthus at the outermost portion of the bony orbital rim, correlatingapproximately with the 10 o'clock position of the orbicularis oculimuscle. Additional injection needle access regions are incorporated intothe wearable injection guide at the half-past-nine position, thehalf-past-8 position and the half-past-7 positions. Each site is furtherincludes one or more fiducials indicating 3 units of botulinum toxin.

Example 2 A Wearable Injection Guide for Treating a Facial Region of anIndividual with Hyaluronic Filler

Construction and use of a rigid, agent coated wearable injection guideare described. The wearable injection guide is constructed of a rigidmaterial based on the topography of the body region of an individual,the rigid material being a porous material substantially impenetrable toan injection needle and including one or more injection needle accessregions, coated with one or more agents and used for treating skin foldsassociated with the nasolabial folds, i.e., “laugh lines,” of anindividual's face with injected hyaluronic acid filler.

A digitally rendered model of a wearable injection guide is generatedfrom one or more digital images of at least a portion an individual'sface with particular emphasis on the nasolabial folds. In an embodiment,the digitally rendered model of the wearable injection guide isgenerated using the image capture methods described in Example 1.Alternatively, the digitally rendered model of the wearable injectionguide is generated using a PRIMOS optical three-dimensional in vivo skinmeasurement device (GFMesstechnik, Teltow, Germany). This systemprojects structured light, e.g., a parallel stripe pattern, onto thebody region of the individual which is depicted on a charge-coupleddevice chip of a shooting camera through a shooting optic. Themeasurement system consists of a freely movable optical measurement head(with an integrated micro-mirror projector, a projection optic, ashooting optic, and a charge-coupled device recording camera) togetherwith a computer system. The three-dimensional effect is achieved bydeflection of the parallel projection stripes by the topography of thebody region of the individual. The deflections are digitalized andquantitatively evaluated using software. Mathematical algorithms areused to generate a three-dimensional image of the body region of theindividual which becomes the basis for the digitally rendered model ofthe wearable injection guide (see, e.g., Friedman et al., Dermatol.Surg. (2002) 28:3; Jacobi et al., Skin Res. Technol. (2004) 10:207-214;Levenberg Eur. J. Dermatol. (2010) 20:615-619, which are incorporatedherein by reference).

A pattern of one to ten digitally rendered injection needle accessregions are added to the digitally rendered model of the wearableinjection guide. Injection of hyaluronic acid into the nasolabial foldscan be done at a single injection site by the process of threading or atmultiple injection sites along the fold. Threading involves injectingthe needle under the skin all the way to a distant point and then slowlyremoving the needle while releasing the injectable agent. To accommodatethreading, in which the injection needle is injected at an angle ofabout 10 to 30 degrees relative to the body region, the digitallyrendered injection needle access regions are modeled into the digitallyrendered model of the wearable injection guide at an angle of less than90 degrees relative to the surface of the wearable injection guide. Ifmultiple injection sites are used, multiple digitally rendered injectionneedle access regions are modeled into the digitally rendered model ofthe wearable injection guide along the linear path of the nasolabialfold.

One or more digitally rendered fiducials are also added to the digitallyrendered model of the wearable injection guide indicating the dosage ofhyaluronic acid filler to be used at each injection site. For injectioninto the nasolabial folds, the injection volume can be as high as 6 mlper fold, although preferably 1-3 ml per fold, and depends upon thedepth of the folds and how much “correction” is desired by theindividual. The physician or other practitioner can determine theappropriate dosage of the hyaluronic filler by assessing the depth ofthe nasolabial fold from viewing either the individual's face directlyor the captured and processed three-dimensional image of theindividual's face on a computer monitor (see, e.g., Prager & SteinkrausEur. J. Dermatol. (2010) 20:748-752, which is incorporated herein byreference). Alternatively, the computing device used to generate thedigitally rendered model of the wearable injection guide can include oneor more algorithms to determine the appropriate dosage based on thecaptured image information.

The wearable injection guide is produced by 3D printing from thedigitally rendered model of the wearable injection guide as described inExample 1. Alternatively, the wearable injection guide is produced by 3Dprinting from the digitally rendered model of the wearable injectionguide using a laser sintering process with a powder starting material.For example, hydroxyapatite powder in combination with a polymer-basedbinder solution can be used to generate a porous ceramic-like structure(see, e.g., Seitz et al., J. Biomed. Mater. Res. Part B: Appl. Biomater(2005) 74B:782-788, which is incorporated herein by reference). Theporous inner surface of the resulting wearable injection guide is coatedwith a disinfectant, e.g., a 7% povidine-iodine solution and with aeutectic mix of local anesthetic lidocaine (2.5%) and prilocaine (2.5%).The inner surface of the wearable injection guide is covered with aprotective sheet to prevent the disinfectant and anesthetic fromprematurely flowing away.

The surface of the individual's face is wiped with a disinfectant, e.g.,rubbing alcohol, and the wearable injection guide is immobilized on theindividual's face using Velcro® straps. The hyaluronic acid filler forinjection is preferably one of the agents approved by the United StatesFood & Drug Administration (FDA), e.g., Restylane® (from MedicisAesthetics Inc., Scottsdale, Ariz.). Restylane is provided by themanufacturer in a disposable glass syringe. Needles ½ inch in length andeither 29 or 30 gauge are recommended for use with this product.Injection of the hyaluronic acid filler through the wearable injectionguide is carried out based on the placement of the injection needleaccess regions and the one or more fiducials indicating the treatmentparameters.

Example 3

A Wearable Injection Guide for Treating Blepharospasm (Eye-lid Spasm)with Botulinum Toxin

Construction and use of a wearable injection guide are described. Thewearable injection guide is constructed of a rubber-like needlepenetrable material based on a digitally rendered model of the wearableinjection guide that includes topography of a body region of anindividual and used for treating blepharospasm (eye-lid spasm) withbotulinum toxin.

A digitally rendered model of the wearable injection guide is generatedfrom one or more digital images of the body region of an individual'sface, with particular emphasis on the eye-lids. In an embodiment, thedigitally rendered model of the wearable injection guide can begenerated using the image capture and modeling methods described inExample 1 or Example 2. Alternatively, three-dimensional images arecaptured with the DSP400 and MU2 photogrammetric face scanners,non-contact scanners for capturing photographic images from multiple,e.g., four, viewpoints using separate charge-coupled device cameras(from, 3dMD, Atlanta, Ga.). Various landmarks on the face are used toalign the images and can include the inner and outer canthi of botheyes, the center of the upper lip, the outer corners of the mouth, theintersection of the frontal bone and two nasal bones of the skull(nasion), the tip of the nose (pronasale), a subnasal point, and a chinpoint. The images are used to form a three-dimensional image that isincorporated into the digitally rendered model of the wearable injectionguide using one or more of a three-dimensional modeling software program(see, e.g., Gwilliam et al., Eur. J. Orthodontics (2006) 28:408-415,which is incorporated herein by reference).

One or more digitally rendered fiducials indicative of at least onetreatment parameter pertaining to injection of botulinum toxin are addedto the digitally rendered model of the wearable injection guide for useover the eye-lid area of the individual. For the treatment ofblepharospasm with a botulinum toxin, e.g., BOTOX® (from, Allergan,Inc., Irvine, Calif.), the one or more digitally rendered fiducials areplaced on the digitally rendered model on portions of the guidecorresponding to regions either proximal to or over the medial andlateral pre-tarsal orbicularis oculi of the upper lid and into thelateral pre-tarsal orbicularis oculi of the lower lid. Care is taken notto place injection sites near the levator palpebrae superioris and themedial lower lid to avoid complications of ptosis and diplopia,respectively. A series of 5 to 10 digitally rendered fiducialscorresponding with 5 to 10 individual injection sites per eye are addedto the digitally rendered model of the wearable injection guide as wellas an indication of how many units of botulinum toxin should beinjected, e.g., 1.25 to 3.0 units per injection, for a total of 30 unitsper eye. The one or more digitally rendered fiducials are also placed toavoid injection into an underlying blood vessel. The location ofunderlying blood vessels can be imaged using a light emitting diodeillumination system such as that described in U.S. Patent Application2008/0306392, which is incorporated herein by reference. The resultingimages are incorporated into the digitally rendered model of thewearable injection guide to guide placement of the one or more digitallyrendered fiducials to avoid having the final fiducials on the formedwearable injection guide overlapping with an underlying blood vessel.

The digitally rendered model of the wearable injection guide isconstructed such that the inner surface is separated from the outersurface by a distance that allows injection needles of a certain lengthto only reach a certain depth into the underlying tissue of the bodyregion. For example, the inner surface can be uniformly separated fromthe outer surface by a fixed thickness, e.g., 2 mm.

The digitally rendered model of the wearable injection guide with a 2 mmthickness is printed using a rubber-like elastomer, e.g., TangoPlus™(from Objet Inc., Billeric, Mass.) to generate a wearable injectionguide that allows for penetration of an injection needle, but only tothe hub of the needle. As such, a needle 4 mm in length only reaches adepth of 2 mm into the underlying tissue of the body region wheninserted through a wearable injection guide with a thickness of 2 mm.

The wearable injection guide is affixed to the individual's face witheither an adhesive or straps. For example, one or more pieces of doublestick tape are stuck to the inner surface of the wearable injectionguide and subsequently used to adhere the wearable injection guide tothe individual's face. BOTOX® is prepared for injection per themanufacturer's instructions. A 30 gauge needle with a length of 4 mm isused for injecting 1-3 units of BOTOX® per injection site depending uponthe content of the one or more fiducials. The injection needles areinserted through the needle-penetrable material of the wearableinjection guide per the one or more fiducials to a stop point defined bythe hub of the injection needle and the BOTOX is injected into theunderlying eyelid area to a depth of 2 mm. Each treatment lastsapproximately three months, following which the procedure may berepeated. At that time, the one or more fiducials related to dosing andposition of injection may be modified and a new wearable injection guideprinted.

Example 4

A Wearable Injection Guide for Self-injection of Ovulation StimulationHormones

A wearable injection guide for self-injecting one or more hormones intothe upper thigh to induce ovulation as part of in-vitro fertilizationtherapy is constructed from a digitally rendered model of the wearableinjection guide based on one or more digital images of the body regionof the individual.

One or more digital images of the body region of the upper thigh of theindividual are acquired using one of the methods previously describedherein. Alternatively, one or more digital images of the body region ofthe upper thigh of the individual is acquired with a standard digitalcamera and combined with one or more images of blood vessels at or nearthe surface of the skin. An example of an apparatus for imaging bloodvessels is described in U.S. Pat. No. 6,522,911, which is incorporatedherein by reference. When intended for use on the upper thigh of anindividual, the topography of the body region may or may not beincorporated into the digitally rendered model of the wearable injectionguide. However, topographical landmarks, e.g., freckles, moles, tattoos,etc., associated with the body region of the upper thigh can be used asreference points for adding one or more digitally rendered alignmentmarks to the digitally rendered model of the wearable injection guide.

A series of digitally rendered injection needle-access regions are addedto the digitally rendered model of the wearable injection guide. Thenumber of access regions is dependent upon the number of plannedinjections during the ovulation cycle, which is further dependent uponthe types of injectable hormones used. Eggs are matured in vivo prior toharvesting for in vitro fertilization using some combination ofgonadotropin-releasing hormone (GnRH) antagonists, follicle-stimulatinghormone (FSH), and human chorionic gonadotropin (hCG). In this example,the wearable injection guide is designed for use with multipleinjections of the GnRH antagonist leuprolide acetate, e.g., Lupron, andFSH over the course of 14 to 21 days and a final injection with hCG twodays prior to harvesting eggs and is individualized to the individual'smenstrual cycle. One or more digitally rendered fiducials indicative ofat least one treatment parameter are added to the digitally renderedmodel of the wearable injection prior to manufacture. The one or moredigitally rendered fiducials indicate the type of drug to be injected,the dose of drug to be injected, and/or the day in the treatment cycle.The one or more digitally rendered fiducials are added proximal to thedigitally rendered injection needle-access regions on the digitallyrendered model of the wearable injection guide. The wearable injectionguide is produced from the completed digitally rendered model of thewearable injection guide using one of the manufacturing methodsdescribed herein.

An illustrative example of a wearable injection guide for self-injectionof Lupron and FSH over the course of 14 to 21 days is provided in FIG.44. Wearable injection guide 4400 configured for placement on the bodyregion of the upper thigh 4410 of an individual includes a series ofinjection needle access regions 4430. The wearable injection guide 4400has an orientation 4420 that allows the user to decipher the one or morefiducials, e.g., letters and/or numbers, on the wearable injection guide4400 when it is deployed on the user's upper thigh 4410 but wouldotherwise appear upside-down to another person viewing the wearableinjection guide 4400 on said user's upper thigh 4410.

In this example, the wearable injection guide is adhered to the upperthigh using a reversible adhesive. The wearable injection guide can beleft in place for the full treatment period or removed after each dailyinjection. One or more alignment marks on the wearable injection guideare used to align the wearable injection guide to references points onthe skin of the upper thigh, e.g., two or more freckles. In general, theinjection cycle is as follows: On day 1 (which corresponds to day 21 ofthe menstrual cycle) the injection cycle is initiated by injecting thefirst Lupron injection. On day 9-12 (which corresponds to the day afterthe beginning of menstruation and is variable depending upon number ofdays in cycle) initiate 7 days of FSH injection. On day 16, finishinjection cycle with last injections of Lupron and FSH and a singleinjection of HCG. Egg retrieval is done 2 days after HCG injection. Oneor more fiducials are included on the wearable injection guide to guidethe individual on appropriate daily injections. In the non-limitingexample depicted in FIG. 44, a first column 4440 of injection needleaccess regions 4430 are marked with an “L” for Lupron and numbered in adescending manner to indicate the first day of Lupron injection, thesecond day of Lupron injection, etc., out to the twelfth day of Luproninjection. A second column 4450 and a third column 4460 of injectionneedle access regions 4430 are marked with an “L” and “FSH” respectivelyand are similarly numbered to indicate the injection day. The fourthcolumn 4470 contains a single injection needle access region 4430reserved for the final injection with hCG two days prior to harvestingof eggs. In some instances, oral birth control pills may be combinedwith the injections to control the menstrual cycle. In this instance,12-21 days of oral birth control pills may be given prior to initiationof Lupron injections.

The wearable injection guide for use in fertility treatment can includean alternative treatment regimen. For example, a second treatment optionincludes oral birth control pills, followed by injection of FSH and theGnRN antagonist Ganirelix. In this regimen, the wearable injection guideincludes one or more fiducials indicating 6 separate injections of FSH,followed by combined injection of FSH and Ganirelix for 4 days, followedby a final injection of HCG. Prior to initiating injection treatment,oral birth control pills are given for 17 days at which point pills arestopped. This is day 1. At day 6, daily FSH injection is started. At day11, daily Ganirelix injection is added and on day 14, the injectiontreatment regimen ends with HCG injection. Eggs are retrieved 2 dayslater.

Example 5

A Wearable Injection Guide with One or More Activatable Injection EventIndicators

A wearable injection guide for guiding injection of an injectable agentincluding one or more activatable injection event indicators isdescribed for use in self-injection of an injectable agent, e.g., anantibiotic, into the upper thigh. In this example, the antibiotic isRocephin® (from Genentech USA Inc., South San Francisco, Calif.), abroad-spectrum cephalosporin antibiotic.

One or more digital images of the body region of the individual's upperthigh are acquired by a digital camera and transferred to a computingdevice. The one or more digital images include one or more referencepoints, e.g., freckles, associated with the body region of theindividual's thigh. If no reference points are available on the bodyregion, the physician or other practitioner may place one or more marks,e.g., semi-permanent ink spots, on the body region for use as one ormore reference points. The digital images including the one or morereference points are used to generate a digitally rendered model of thewearable injection guide. One or more digitally rendered alignment markscoinciding with the one or more reference points on the body region areadded to the digitally rendered model of the wearable injection guide.

One or more digitally rendered fiducials indicative of at least onetreatment parameter are added to the digitally rendered model of thewearable injection guide. The one or more digitally rendered fiducialsindicate the treatment parameters for Rocephin®, the latter of whichdepend upon the severity of the infection. The recommended dose forRocephin is 1 to 2 grams given once a day (or in equally divided dosestwice a day) for 4 to 14 days, and possibly longer for complicatedinfections. For infections caused by Staphylococcus aureus (MSSA), forexample, the recommended daily dose is 2 to 4 grams, not to exceed 4grams. One or more fiducials are digitally added to digitally renderedmodel of the wearable injection guide reflecting the dosing recommendedby the physician or other practitioner. For 2 grams daily over 14 days,each of 28 injection sites on the wearable injection guide are markedwith one or more fiducials indicating the dose (1 gram), the time of day(day or night) and the day (1-14). The specific treatment parameters arespecified by the patient's caregiver.

The wearable injection guide is formed from the digitally rendered modelof the wearable injection guide using a 3D printing method. Preferablyat least a portion of the wearable injection guide is transparent suchthat alignment marks on the wearable injection guide can be aligned withone or more underlying reference points, e.g., freckles, on the bodyregion. A transparent wearable injection guide is formed from thedigitally rendered model of the wearable injection guide using 3Dprinting with Objet FullCure720™ using an Objet Connex 3D printer (from,Objet Inc., Billeric, Mass.). To form a more rubber-likesemi-translucent wearable injection guide, the digitally rendered modelof the wearable injection guide can be printed using Objet TangoPlusFullCure930 and an Eden 3-Dimensional Printing System (both from ObjetInc., Billeric, Mass.).

Once the wearable injection guide is printed, a layer of pressuresensitive film, e.g., FujiFilm Prescale extreme low pressure film(distributed by Tekscan, Inc., Boston, Mass.) is adhered to the outersurface of the wearable injection guide. The pressure sensitive film isused as an activatable injection event indicator to indicate whether ornot a given area of the wearable injection guide has been previouslyaccessed. In some embodiments, at least a portion of the pressuresensitive film is transparent, enabling the intended user to be able toread the one or more fiducials that have been otherwise printed on thewearable injection guide. Alternatively, the pressure sensitive film issituated such that the one or more fiducials are readable relative toplacement of the pressure sensitive film. One or more biocompatibleadhesive strips are affixed to the inner surface of the wearableinjection guide and used to adhere the wearable injection guide to thebody region of the individual.

Prior to deploying the wearable injection guide, the body region of theindividual's thigh is thoroughly swabbed with alcohol to disinfect thearea. The wearable injection guide is deployed onto the body region ofthe individual by aligning the one or more alignment marks on thewearable injection guide with one or more reference points on the bodyregion. A 500 milligram (mg) vial of Rocephin powder is reconstitutedwith 1 ml of an appropriate diluent, e.g., sterile water, to a finalconcentration of 350 mg/ml. Alternatively, the Rocephin powder can bereconstituted in 1% lidocaine hydrochloride to ease the pain ofinjection. A 3 ml syringe with a 1½ inch 22 gauge needle is used toinject the appropriate dose of Rocephin through the wearable injectionguide at the appropriate site and into the underlying intramuscularregion of the thigh. The appropriate site is based on the one or morefiducials and whether or not the activatable injection event indicatorhas been previously activated.

All of the above U.S. patents, U.S. patent application publications,U.S. patent applications, foreign patents, foreign patent applicationsand non-patent publications referred to in this specification and/orlisted in any Information Disclosure Statement, are incorporated hereinby reference, to the extent not inconsistent herewith.

With respect to the appended claims, the recited operations therein maygenerally be performed in any order. Also, although various operationalflows are presented in a sequence(s), it should be understood that thevarious operations may be performed in other orders than those which areillustrated, or may be performed concurrently. Examples of suchalternate orderings may include overlapping, interleaved, interrupted,reordered, incremental, preparatory, supplemental, simultaneous,reverse, or other variant orderings, unless context dictates otherwise.Furthermore, terms like “responsive to,” “related to,” or otherpast-tense adjectives are generally not intended to exclude suchvariants, unless context dictates otherwise.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.The various aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopeand spirit being indicated by the following claims.

What is claimed is:
 1. A personalized wearable injection guidecomprising: a rigid needle-penetrable material having an inner surfaceand an outer surface, the inner surface fabricated based on a specifictopography of a patient's face to substantially conform in shape tocontours of the patient's face, the outer surface including one or morefiducials arranged in a treatment pattern determined by a distributionof facial lines or wrinkles on the patient's face, the one or morefiducials indicative of at least one of a type and a dose of aninjectable agent to be injected at said one or more fiducials; and oneor more activatable injection event indicators associated with the rigidneedle-penetrable material, at least one of the one or more activatableinjection event indicators coincident with at least one of the one ormore fiducials.
 2. The personalized wearable injection guide of claim 1,wherein the outer surface of the rigid needle-penetrable materialcomprises: an outer contour with one or more portions separated from theinner surface of the rigid needle-penetrable material by two or moreneedle depth-limiting distances.
 3. The personalized wearable injectionguide of claim 1, wherein the one or more fiducials indicative of the atleast one of the type and the dose of the injectable agent to beinjected at said one or more fiducials comprise: one or more shapes,colors, numbers, letters, crosshairs, or combinations thereof indicativeof the at least one of the type and the dose of the injectable agent tobe injected at said one or more fiducials.
 4. The personalized wearableinjection guide of claim 1, wherein the one or more fiducials indicativeof the at least one of the type and the dose of the injectable agent tobe injected at said one or more fiducials comprise: one or morefiducials indicative of at least one of a type and a dose of aninjectable neurotoxin to be injected at said one or more fiducials. 5.The personalized wearable injection guide of claim 1, wherein the one ormore fiducials indicative of the at least one of the type and the doseof the injectable agent to be injected at said one or more fiducialscomprise: one or more fiducials indicative of at least one of a type anda dose of an injectable subcutaneous volume enhancer to be injected atsaid one or more fiducials.
 6. The personalized wearable injection guideof claim 1, wherein the one or more fiducials indicative of the at leastone of the type and the dose of the injectable agent to be injected atsaid one or more fiducials comprise: one or more fiducials indicative ofat least one of a type and a dose of an injectable dermal filler to beinjected at said one or more fiducials.
 7. The personalized wearableinjection guide of claim 1, wherein at least one of the one or moreactivatable injection event indicators associated with the rigidneedle-penetrable material is positioned on top of at least a portion ofthe outer surface of the rigid needle-penetrable material.
 8. Thepersonalized wearable injection guide of claim 1, wherein at least oneof the one or more activatable injection event indicators associatedwith the rigid needle-penetrable material is incorporated into at leasta portion of the outer surface or the inner surface of the rigidneedle-penetrable material.
 9. The personalized wearable injection guideof claim 1, wherein at least one of the one or more activatableinjection event indicators associated with the rigid needle-penetrablematerial is incorporated into at least a portion of the rigidneedle-penetrable material between the outer surface of the rigidneedle-penetrable material and the inner surface of the rigidneedle-penetrable material.
 10. The personalized wearable injectionguide of claim 1, wherein at least one of the one or more activatableinjection event indicators associated with the rigid needle-penetrablematerial comprises: at least one pressure sensitive material.
 11. Thepersonalized wearable injection guide of claim 1, wherein at least oneof the one or more activatable injection event indicators associatedwith the rigid needle-penetrable material comprises: one or moreflowable dyes.
 12. The personalized wearable injection guide of claim 1,wherein at least one of the one or more activatable injection eventindicators associated with the rigid needle-penetrable materialcomprises: one or more of an oxygen-sensitive dye or a moisturesensitive dye.
 13. The personalized wearable injection guide of claim 1,wherein at least a portion of the inner surface of the rigidneedle-penetrable material comprises: one or more of an analgesic, adisinfectant, an antiseptic, a sterilant, or a therapeutic agent. 14.The personalized wearable injection guide of claim 1, furthercomprising: a reversible adhesive on the inner surface of the rigidneedle-penetrable material.
 15. The personalized wearable injectionguide of claim 1, further comprising: at least one head-encircling pieceattached to the rigid needle-penetrable material.
 16. A method ofadministering an injection treatment to a patient comprising: insertingone or more injection needles through a rigid needle-penetrable materialof a personalized wearable injection guide at or near one or morefiducials, the personalized wearable injection guide including the rigidneedle-penetrable material having an inner surface and an outer surface,the inner surface fabricated based on a specific topography of thepatient's face to substantially conform in shape to contours of thepatient's face, the outer surface including the one or more fiducialsarranged in a treatment pattern determined by a distribution of faciallines or wrinkles on the patient's face, the one or more fiducialsindicative of at least one of a type and a dose of an injectable agentto be injected at said one or more fiducials, and one or moreactivatable injection event indicators associated with the rigidneedle-penetrable material and coincident with at least one of the oneor more fiducials; activating at least one of the one or moreactivatable injection event indicators during insertion of the one ormore injection needles through the rigid needle-penetrable material; andinjecting at least one injectable agent through the one or moreinjection needles into an underlying tissue of the patient's face inproximity to at least one of the facial lines or wrinkles on thepatient's face.
 17. The method of claim 16, further comprising: aligningthe personalized wearable injection guide with one or more referencepoints on the patient's face.
 18. The method of claim 17, whereinaligning the personalized wearable injection guide with the one or morereferences points on the patient's face comprises: aligning thepersonalized wearable injection guide with one or more topographicallandmarks on the patient's face.
 19. The method of claim 17, whereinaligning the personalized wearable injection guide with the one or morereferences points on the patient's face comprises: aligning thepersonalized wearable injection guide with one or more pigmentation,pigmented area, skin texture pattern, tattoo, blemish, scar, anatomicalfeature, or subsurface blood vessel on the patient's face.
 20. Themethod of claim 16, further comprising: reversibly adhering thepersonalized wearable injection guide on the patient's face with anadhesive.
 21. The method of claim 16, further comprising: immobilizingthe personalized wearable injection guide on the patient's face with oneor more head-encircling pieces.
 22. The method of claim 16, whereininserting the one or more injection needles through the rigidneedle-penetrable material of the personalized wearable injection guideat or near the one or more fiducials comprises: inserting the one ormore injection needles at less than a 90 degree angle relative to theouter surface of the personalized wearable injection guide.
 23. Themethod of claim 16, wherein injecting at least one injectable agentthrough the one or more injection needles into an underlying tissue ofthe patient's face in proximity to at least one of the facial lines orwrinkles on the patient's face comprises: injecting at least oneneurotoxin.
 24. The method of claim 16, wherein injecting at least oneinjectable agent through the one or more injection needles into anunderlying tissue of the patient's face in proximity to at least one ofthe facial lines or wrinkles on the patient's face comprises: injectingat least one of a subcutaneous volume enhancer or a dermal filler. 25.The method of claim 16, further comprising: verifying that thepersonalized wearable injection guide is appropriate for the patientwith one or more patient identifiers associated with the personalizedwearable injection guide.
 26. The method of claim 16, furthercomprising: altering the temperature of the wearable injection guide toa temperature above or below about 98.6 degrees Fahrenheit.